Doug Brunk

DENVER – The higher the power of an e-cigarette, the higher the concentrations of potentially hazardous substances the device produces, including acetaldehyde, acrolein, and formaldehyde.

Those are among the findings presented at an international conference of the American Thoracic Society by lead study author Dr. Daniel Sullivan, an internal medicine resident at the University of Texas Southwestern Medical Center. During his previous training at the University of Alabama, Birmingham, Dr. Sullivan and his associates used a variety of methods including liquid chromatography–mass spectrometry and enzyme-linked immunosorbent assay (ELISA) to study components and nicotine formulations typical of e-cigarette users. Under some test conditions, formaldehyde levels were comparable to those seen in traditional tobacco cigarettes, he said in a video interview.

Dr. Sullivan reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

DENVER – The higher the power of an e-cigarette, the higher the concentrations of potentially hazardous substances the device produces, including acetaldehyde, acrolein, and formaldehyde.

Those are among the findings presented at an international conference of the American Thoracic Society by lead study author Dr. Daniel Sullivan, an internal medicine resident at the University of Texas Southwestern Medical Center. During his previous training at the University of Alabama, Birmingham, Dr. Sullivan and his associates used a variety of methods including liquid chromatography–mass spectrometry and enzyme-linked immunosorbent assay (ELISA) to study components and nicotine formulations typical of e-cigarette users. Under some test conditions, formaldehyde levels were comparable to those seen in traditional tobacco cigarettes, he said in a video interview.

Dr. Sullivan reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

DENVER – The higher the power of an e-cigarette, the higher the concentrations of potentially hazardous substances the device produces, including acetaldehyde, acrolein, and formaldehyde.

Those are among the findings presented at an international conference of the American Thoracic Society by lead study author Dr. Daniel Sullivan, an internal medicine resident at the University of Texas Southwestern Medical Center. During his previous training at the University of Alabama, Birmingham, Dr. Sullivan and his associates used a variety of methods including liquid chromatography–mass spectrometry and enzyme-linked immunosorbent assay (ELISA) to study components and nicotine formulations typical of e-cigarette users. Under some test conditions, formaldehyde levels were comparable to those seen in traditional tobacco cigarettes, he said in a video interview.

Dr. Sullivan reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

DENVER – Although electronic cigarettes are widely promoted as a smoking cessation tool, no sound data exist to support their use beyond 1 month as a way to kick the smoking habit, results from the largest meta-analysis of its kind suggest.

In an interview at an international conference of the America Thoracic Society, study author Dr. Matthew B. Stanbrook highlighted results from the review, which included 297 articles published to May 2014.

The meta-analysis showed that point prevalence abstinence was significantly better for e-cigarettes, compared with placebo, at 1 month (relative risk, 1.71). That effect, however, was no longer observed at 3- or 6-month follow-ups.

The most common adverse events noted in the studies were dry cough, throat irritation, and shortness of breath.

Dr. Stanbrook reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

DENVER – Although electronic cigarettes are widely promoted as a smoking cessation tool, no sound data exist to support their use beyond 1 month as a way to kick the smoking habit, results from the largest meta-analysis of its kind suggest.

In an interview at an international conference of the America Thoracic Society, study author Dr. Matthew B. Stanbrook highlighted results from the review, which included 297 articles published to May 2014.

The meta-analysis showed that point prevalence abstinence was significantly better for e-cigarettes, compared with placebo, at 1 month (relative risk, 1.71). That effect, however, was no longer observed at 3- or 6-month follow-ups.

The most common adverse events noted in the studies were dry cough, throat irritation, and shortness of breath.

Dr. Stanbrook reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

DENVER – Although electronic cigarettes are widely promoted as a smoking cessation tool, no sound data exist to support their use beyond 1 month as a way to kick the smoking habit, results from the largest meta-analysis of its kind suggest.

In an interview at an international conference of the America Thoracic Society, study author Dr. Matthew B. Stanbrook highlighted results from the review, which included 297 articles published to May 2014.

The meta-analysis showed that point prevalence abstinence was significantly better for e-cigarettes, compared with placebo, at 1 month (relative risk, 1.71). That effect, however, was no longer observed at 3- or 6-month follow-ups.

The most common adverse events noted in the studies were dry cough, throat irritation, and shortness of breath.

Dr. Stanbrook reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

DENVER – Intermittent high-dose nitric oxide (NO) inhalation therapy appears safe and shows clear signals of efficacy in infants hospitalized with bronchiolitis, a randomized controlled trial showed.

“Further larger scale clinical trials are needed to establish its role in lower respiratory tract infections such as viral bronchiolitis, pneumonia, cystic fibrosis, viral-related asthma, COPD [chronic obstructive pulmonary disease], and more,” one of the study authors, Yossef Av-Gay, Ph.D., said in an interview in advance of an international conference of the American Thoracic Society.

In what they said is the first human study of its kind, researchers led by Dr. Asher Tal, head of the pediatric pulmonary unit at Soroka University Medical Center, Beer Sheva, Israel, set out to determine the safety and tolerability of intermittent high-dose inhaled NO for the treatment of hospitalized infants aged 2-12 months with bronchiolitis. Patients received either 160 parts per million (ppm) of NO five times per day for 30 minutes each time or oxygen only.

At lower concentrations, nitric oxide is a pulmonary vasodilator. It has been studied in the 1-60 ppm range and received Food and Drug Administration approval in 1999.* "Nitric oxide gas is used to treat neonates at lower dose, and in this study we investigated its antimicrobial dosage, which is higher than current treatment,” said Dr. Av-Gay, professor of the division of infectious diseases at the University of British Columbia, Vancouver.

“Previous in-vitro and in animal studies support the antimicrobial effect of intermittent inhalations of 160 ppm of NO to treat lower respiratory tract infections, both viral and bacterial. Bronchiolitis is a viral-related [infection] that causes significant morbidity and even mortality in infants around the world. Presently the treatment protocol for hospitalized infants is supportive care only, because despite many years of research as there is not yet an available treatment or specific anti-viral drug. Inhaled NO is thus an exciting potential novel drug for the treatment of acute bronchiolitis,” he said.

Of 43 infants initially enrolled, 25 were hospitalized for more than 24 hours and were considered evaluable for efficacy. Of these, 14 received intermittent high-dose inhaled NO and 11 received oxygen only. The researchers observed no significant differences between the NO and oxygen groups in the number of adverse events or in the number of serious adverse events. Patients who received NO, however, spent significantly fewer hours in the hospital, compared with the oxygen group (mean of 46 hours vs. 74 hours, respectively; P = .032) and reached 92% oxygen saturation in significantly faster time (mean of 26 hours vs. 61 hours; P = .032).

Dr. Av-Gay acknowledged certain limitations of the analysis, including the fact that the study’s primary outcome was safety and tolerability. “Therefore, the study was not powered to show efficacy,” he said.

The study was funded by Advanced Inhalation Therapies, an Israeli-based company that holds the rights to the NO technology. Dr. Av-Gay is the company’s chief scientific officer, and Dr. Tal is employed by the company.

[email protected]

On Twitter @dougbrunk

*This article was added to on 6/25/15.

DENVER – Intermittent high-dose nitric oxide (NO) inhalation therapy appears safe and shows clear signals of efficacy in infants hospitalized with bronchiolitis, a randomized controlled trial showed.

“Further larger scale clinical trials are needed to establish its role in lower respiratory tract infections such as viral bronchiolitis, pneumonia, cystic fibrosis, viral-related asthma, COPD [chronic obstructive pulmonary disease], and more,” one of the study authors, Yossef Av-Gay, Ph.D., said in an interview in advance of an international conference of the American Thoracic Society.

In what they said is the first human study of its kind, researchers led by Dr. Asher Tal, head of the pediatric pulmonary unit at Soroka University Medical Center, Beer Sheva, Israel, set out to determine the safety and tolerability of intermittent high-dose inhaled NO for the treatment of hospitalized infants aged 2-12 months with bronchiolitis. Patients received either 160 parts per million (ppm) of NO five times per day for 30 minutes each time or oxygen only.

At lower concentrations, nitric oxide is a pulmonary vasodilator. It has been studied in the 1-60 ppm range and received Food and Drug Administration approval in 1999.* "Nitric oxide gas is used to treat neonates at lower dose, and in this study we investigated its antimicrobial dosage, which is higher than current treatment,” said Dr. Av-Gay, professor of the division of infectious diseases at the University of British Columbia, Vancouver.

“Previous in-vitro and in animal studies support the antimicrobial effect of intermittent inhalations of 160 ppm of NO to treat lower respiratory tract infections, both viral and bacterial. Bronchiolitis is a viral-related [infection] that causes significant morbidity and even mortality in infants around the world. Presently the treatment protocol for hospitalized infants is supportive care only, because despite many years of research as there is not yet an available treatment or specific anti-viral drug. Inhaled NO is thus an exciting potential novel drug for the treatment of acute bronchiolitis,” he said.

Of 43 infants initially enrolled, 25 were hospitalized for more than 24 hours and were considered evaluable for efficacy. Of these, 14 received intermittent high-dose inhaled NO and 11 received oxygen only. The researchers observed no significant differences between the NO and oxygen groups in the number of adverse events or in the number of serious adverse events. Patients who received NO, however, spent significantly fewer hours in the hospital, compared with the oxygen group (mean of 46 hours vs. 74 hours, respectively; P = .032) and reached 92% oxygen saturation in significantly faster time (mean of 26 hours vs. 61 hours; P = .032).

Dr. Av-Gay acknowledged certain limitations of the analysis, including the fact that the study’s primary outcome was safety and tolerability. “Therefore, the study was not powered to show efficacy,” he said.

The study was funded by Advanced Inhalation Therapies, an Israeli-based company that holds the rights to the NO technology. Dr. Av-Gay is the company’s chief scientific officer, and Dr. Tal is employed by the company.

[email protected]

On Twitter @dougbrunk

*This article was added to on 6/25/15.

DENVER – Intermittent high-dose nitric oxide (NO) inhalation therapy appears safe and shows clear signals of efficacy in infants hospitalized with bronchiolitis, a randomized controlled trial showed.

“Further larger scale clinical trials are needed to establish its role in lower respiratory tract infections such as viral bronchiolitis, pneumonia, cystic fibrosis, viral-related asthma, COPD [chronic obstructive pulmonary disease], and more,” one of the study authors, Yossef Av-Gay, Ph.D., said in an interview in advance of an international conference of the American Thoracic Society.

In what they said is the first human study of its kind, researchers led by Dr. Asher Tal, head of the pediatric pulmonary unit at Soroka University Medical Center, Beer Sheva, Israel, set out to determine the safety and tolerability of intermittent high-dose inhaled NO for the treatment of hospitalized infants aged 2-12 months with bronchiolitis. Patients received either 160 parts per million (ppm) of NO five times per day for 30 minutes each time or oxygen only.

At lower concentrations, nitric oxide is a pulmonary vasodilator. It has been studied in the 1-60 ppm range and received Food and Drug Administration approval in 1999.* "Nitric oxide gas is used to treat neonates at lower dose, and in this study we investigated its antimicrobial dosage, which is higher than current treatment,” said Dr. Av-Gay, professor of the division of infectious diseases at the University of British Columbia, Vancouver.

“Previous in-vitro and in animal studies support the antimicrobial effect of intermittent inhalations of 160 ppm of NO to treat lower respiratory tract infections, both viral and bacterial. Bronchiolitis is a viral-related [infection] that causes significant morbidity and even mortality in infants around the world. Presently the treatment protocol for hospitalized infants is supportive care only, because despite many years of research as there is not yet an available treatment or specific anti-viral drug. Inhaled NO is thus an exciting potential novel drug for the treatment of acute bronchiolitis,” he said.

Of 43 infants initially enrolled, 25 were hospitalized for more than 24 hours and were considered evaluable for efficacy. Of these, 14 received intermittent high-dose inhaled NO and 11 received oxygen only. The researchers observed no significant differences between the NO and oxygen groups in the number of adverse events or in the number of serious adverse events. Patients who received NO, however, spent significantly fewer hours in the hospital, compared with the oxygen group (mean of 46 hours vs. 74 hours, respectively; P = .032) and reached 92% oxygen saturation in significantly faster time (mean of 26 hours vs. 61 hours; P = .032).

Dr. Av-Gay acknowledged certain limitations of the analysis, including the fact that the study’s primary outcome was safety and tolerability. “Therefore, the study was not powered to show efficacy,” he said.

The study was funded by Advanced Inhalation Therapies, an Israeli-based company that holds the rights to the NO technology. Dr. Av-Gay is the company’s chief scientific officer, and Dr. Tal is employed by the company.

[email protected]

On Twitter @dougbrunk

*This article was added to on 6/25/15.

DENVER – The use of nintedanib 150 mg twice daily has been shown to slow disease progression in patients with idiopathic pulmonary fibrosis up to 76 weeks of treatment, with an acceptable safety and tolerability profile, according to results from a novel study.

Marketed by Boehringer Ingelheim, nintedanib (Ofev)was approved by the FDA in October of 2014 for the treatment of idiopathic pulmonary fibrosis. Data from period 1 of the dose-finding, phase II TOMORROW trial (N. Engl. J. Med. 2011;365:1079–87) and the two replicate Phase III INPULSIS trials (N. Engl. J. Med. 2014;370:2071-82) demonstrated the efficacy and safety of nintedanib 150 mg twice daily over 52 weeks in patients with IPF. After completing period 1 of the TOMORROW trial, study participants had the option to continue treatment in a further blinded treatment phase (period 2).

“Clinicians are always interested in the long-term efficacy and safety of a new drug in patients suffering from a chronic, progressive disease like IPF,” lead study author Dr. Luca Richeldi said in an interview in advance of an international conference of the American Thoracic Society. “These data from period 2 of the TOMORROW trial are the first data to be generated on long-term treatment with nintedanib, i.e., beyond 52 weeks.” In period 2, patients treated with nintedanib in period 1 continued their dose, while placebo-treated patients were switched to nintedanib 50 mg once daily. The researchers evaluated change in forced vital capacity (FVC), acute exacerbations, mortality and adverse events in the nintedanib 150 mg twice daily group vs. the comparator group (placebo/nintedanib 50 mg once daily).

Of the 428 patients treated in period 1, 316 patients completed period 1 and 286 patients continued treatment in period 2. Of these 286 patients, 48 continued to receive nintedanib 150 mg twice daily and 54 were switched from placebo to nintedanib 50 mg once daily (comparator group), said Dr. Richeldi, professor of respiratory medicine and chair of interstitial lung disease at the University of Southampton (United Kingdom).

Dr. Richeldi reported results from a mean exposure of 14.2 months for the nintedanib 150 mg twice daily group and 16.8 months for the comparator group. Across periods 1 and 2, the researchers observed that the mean change in forced vital capacity (FVC) was consistently lower in the nintedanib 150 mg twice daily group, compared with the comparator group, such that by week 76 the absolute change in the percentage of predicted FVC was -3.1% vs. -6.3%, respectively. In addition, the incidence of acute exacerbations at week 76 was lower in the nintedanib 150 mg twice daily group, compared with the comparator group (3.2 vs. 13.4 per 100 patient-years).

A total of 14 patients (16.3%) died in the nintedanib 150 mg twice daily group, compared with 19 patients (21.8%) in the comparator group. However, the proportion of patients with at least one adverse event across period 1 and 2 was similar between both groups (97.6% vs. 96.5%, respectively), as was the proportion of patients with at least one serious adverse event (30.6% vs. 35.3%).

“It was not a surprise to see that the effect of nintedanib 150 mg twice daily on slowing disease progression (as shown by a reduced decline in FVC) was maintained up to week 76,” Dr. Richeldi said. “In addition, we expected that no relevant changes in the safety and tolerability of nintedanib would be observed in period 2 compared with period 1. We were impressed to see that over 90% of patients who completed the first 52 weeks of treatment in the TOMORROW trial (period 1) chose to continue to receive treatment in period 2.”

One limitation of the study was its small sample size, he said, “with FVC data only being available for 80 patients treated with nintedanib twice daily or comparator at week 76. Data from the open-label extension of the INPULSIS trials, INPULSIS-ON, will provide additional data on the long-term efficacy and safety of nintedanib 150 mg twice daily in patients with IPF.”

The study was supported by Boehringer Ingelheim. Dr. Richeldi disclosed that he has received consultation and speaker’s fees from the company. He was also a member of the steering committee for the TOMORROW trial.

[email protected]

On Twitter @dougbrunk

DENVER – The use of nintedanib 150 mg twice daily has been shown to slow disease progression in patients with idiopathic pulmonary fibrosis up to 76 weeks of treatment, with an acceptable safety and tolerability profile, according to results from a novel study.

Marketed by Boehringer Ingelheim, nintedanib (Ofev)was approved by the FDA in October of 2014 for the treatment of idiopathic pulmonary fibrosis. Data from period 1 of the dose-finding, phase II TOMORROW trial (N. Engl. J. Med. 2011;365:1079–87) and the two replicate Phase III INPULSIS trials (N. Engl. J. Med. 2014;370:2071-82) demonstrated the efficacy and safety of nintedanib 150 mg twice daily over 52 weeks in patients with IPF. After completing period 1 of the TOMORROW trial, study participants had the option to continue treatment in a further blinded treatment phase (period 2).

“Clinicians are always interested in the long-term efficacy and safety of a new drug in patients suffering from a chronic, progressive disease like IPF,” lead study author Dr. Luca Richeldi said in an interview in advance of an international conference of the American Thoracic Society. “These data from period 2 of the TOMORROW trial are the first data to be generated on long-term treatment with nintedanib, i.e., beyond 52 weeks.” In period 2, patients treated with nintedanib in period 1 continued their dose, while placebo-treated patients were switched to nintedanib 50 mg once daily. The researchers evaluated change in forced vital capacity (FVC), acute exacerbations, mortality and adverse events in the nintedanib 150 mg twice daily group vs. the comparator group (placebo/nintedanib 50 mg once daily).

Of the 428 patients treated in period 1, 316 patients completed period 1 and 286 patients continued treatment in period 2. Of these 286 patients, 48 continued to receive nintedanib 150 mg twice daily and 54 were switched from placebo to nintedanib 50 mg once daily (comparator group), said Dr. Richeldi, professor of respiratory medicine and chair of interstitial lung disease at the University of Southampton (United Kingdom).

Dr. Richeldi reported results from a mean exposure of 14.2 months for the nintedanib 150 mg twice daily group and 16.8 months for the comparator group. Across periods 1 and 2, the researchers observed that the mean change in forced vital capacity (FVC) was consistently lower in the nintedanib 150 mg twice daily group, compared with the comparator group, such that by week 76 the absolute change in the percentage of predicted FVC was -3.1% vs. -6.3%, respectively. In addition, the incidence of acute exacerbations at week 76 was lower in the nintedanib 150 mg twice daily group, compared with the comparator group (3.2 vs. 13.4 per 100 patient-years).

A total of 14 patients (16.3%) died in the nintedanib 150 mg twice daily group, compared with 19 patients (21.8%) in the comparator group. However, the proportion of patients with at least one adverse event across period 1 and 2 was similar between both groups (97.6% vs. 96.5%, respectively), as was the proportion of patients with at least one serious adverse event (30.6% vs. 35.3%).

“It was not a surprise to see that the effect of nintedanib 150 mg twice daily on slowing disease progression (as shown by a reduced decline in FVC) was maintained up to week 76,” Dr. Richeldi said. “In addition, we expected that no relevant changes in the safety and tolerability of nintedanib would be observed in period 2 compared with period 1. We were impressed to see that over 90% of patients who completed the first 52 weeks of treatment in the TOMORROW trial (period 1) chose to continue to receive treatment in period 2.”

One limitation of the study was its small sample size, he said, “with FVC data only being available for 80 patients treated with nintedanib twice daily or comparator at week 76. Data from the open-label extension of the INPULSIS trials, INPULSIS-ON, will provide additional data on the long-term efficacy and safety of nintedanib 150 mg twice daily in patients with IPF.”

The study was supported by Boehringer Ingelheim. Dr. Richeldi disclosed that he has received consultation and speaker’s fees from the company. He was also a member of the steering committee for the TOMORROW trial.

[email protected]

On Twitter @dougbrunk

DENVER – The use of nintedanib 150 mg twice daily has been shown to slow disease progression in patients with idiopathic pulmonary fibrosis up to 76 weeks of treatment, with an acceptable safety and tolerability profile, according to results from a novel study.

Marketed by Boehringer Ingelheim, nintedanib (Ofev)was approved by the FDA in October of 2014 for the treatment of idiopathic pulmonary fibrosis. Data from period 1 of the dose-finding, phase II TOMORROW trial (N. Engl. J. Med. 2011;365:1079–87) and the two replicate Phase III INPULSIS trials (N. Engl. J. Med. 2014;370:2071-82) demonstrated the efficacy and safety of nintedanib 150 mg twice daily over 52 weeks in patients with IPF. After completing period 1 of the TOMORROW trial, study participants had the option to continue treatment in a further blinded treatment phase (period 2).

“Clinicians are always interested in the long-term efficacy and safety of a new drug in patients suffering from a chronic, progressive disease like IPF,” lead study author Dr. Luca Richeldi said in an interview in advance of an international conference of the American Thoracic Society. “These data from period 2 of the TOMORROW trial are the first data to be generated on long-term treatment with nintedanib, i.e., beyond 52 weeks.” In period 2, patients treated with nintedanib in period 1 continued their dose, while placebo-treated patients were switched to nintedanib 50 mg once daily. The researchers evaluated change in forced vital capacity (FVC), acute exacerbations, mortality and adverse events in the nintedanib 150 mg twice daily group vs. the comparator group (placebo/nintedanib 50 mg once daily).

Of the 428 patients treated in period 1, 316 patients completed period 1 and 286 patients continued treatment in period 2. Of these 286 patients, 48 continued to receive nintedanib 150 mg twice daily and 54 were switched from placebo to nintedanib 50 mg once daily (comparator group), said Dr. Richeldi, professor of respiratory medicine and chair of interstitial lung disease at the University of Southampton (United Kingdom).

Dr. Richeldi reported results from a mean exposure of 14.2 months for the nintedanib 150 mg twice daily group and 16.8 months for the comparator group. Across periods 1 and 2, the researchers observed that the mean change in forced vital capacity (FVC) was consistently lower in the nintedanib 150 mg twice daily group, compared with the comparator group, such that by week 76 the absolute change in the percentage of predicted FVC was -3.1% vs. -6.3%, respectively. In addition, the incidence of acute exacerbations at week 76 was lower in the nintedanib 150 mg twice daily group, compared with the comparator group (3.2 vs. 13.4 per 100 patient-years).

A total of 14 patients (16.3%) died in the nintedanib 150 mg twice daily group, compared with 19 patients (21.8%) in the comparator group. However, the proportion of patients with at least one adverse event across period 1 and 2 was similar between both groups (97.6% vs. 96.5%, respectively), as was the proportion of patients with at least one serious adverse event (30.6% vs. 35.3%).

“It was not a surprise to see that the effect of nintedanib 150 mg twice daily on slowing disease progression (as shown by a reduced decline in FVC) was maintained up to week 76,” Dr. Richeldi said. “In addition, we expected that no relevant changes in the safety and tolerability of nintedanib would be observed in period 2 compared with period 1. We were impressed to see that over 90% of patients who completed the first 52 weeks of treatment in the TOMORROW trial (period 1) chose to continue to receive treatment in period 2.”

One limitation of the study was its small sample size, he said, “with FVC data only being available for 80 patients treated with nintedanib twice daily or comparator at week 76. Data from the open-label extension of the INPULSIS trials, INPULSIS-ON, will provide additional data on the long-term efficacy and safety of nintedanib 150 mg twice daily in patients with IPF.”

The study was supported by Boehringer Ingelheim. Dr. Richeldi disclosed that he has received consultation and speaker’s fees from the company. He was also a member of the steering committee for the TOMORROW trial.

[email protected]

On Twitter @dougbrunk

SAN DIEGO – Gestational age and postnatal age dependent intestinal barrier maturation in preterm infants may be altered by feeding and antibiotic exposures, a study conducted at two centers showed.

Mature, healthy intestinal mucosa is lined by a monolayer of epithelial cells that forms tight junctions and acts as a selective barrier to bacteria and harmful toxins, Dr. Rose M. Viscardi said at the annual meeting of the Pediatric Academic Societies. Intestinal permeability (IP) defines the leakiness of the mucosal barrier, and previous studies suggest that preterm infants have increased IP at birth that matures over time.

According to Dr. Viscardi, professor of pediatrics at the University of Maryland, Baltimore, increased IP is a risk factor for necrotizing enterocolitis (NEC). IP is disturbed in the newborn, particularly in preterm infants, “because they’re exposed to antibiotics and often delivered by cesarean section,” she said. “This may alter the IP such that there is the potential for bacteria crossing through that paracellular pathway, leading to enhanced neutrophil recruitment and intense inflammatory response both locally in the intestines as well as systematically, leading to the development of NEC.”

Current methods of determining intestinal barrier function include measurements of lactulose (La) and rhamnose (Rh) in urine and plasma, as well as stool alpha 1 antitrypsin (A1AT), a 52-KD glycoprotein produced by the liver, intestinal macrophages, and mucous membrane cells. Dr. Viscardi and her associates set out to determine changes in IP measures by urinary La/Rh and stool A1AT in the first 2 weeks of life in neonates at 24-32 weeks gestational age. The secondary objective was to determine the effect of feeding practices and antibiotic exposure on the IP maturation process in the first 2 weeks of life in those same infants.

At two sites, the researchers enrolled 43 infants at 24-32 weeks gestational age who received 1 mL/kg La/Rh solution (8.6 g La plus 140 mg Rh/100 mL sterile water) administered enterally on study days 1, 8, and 15, with urine collected after 4 hours. The researchers collected .5 mL blood by heel stick 90-120 minutes post La/Rh for serum La/Rh, and stool within 8 hours of La/Rh dose for fecal A1AT and later microbiome analysis.

Of the 43 subjects, 23 (53%) were male, 23 (53%) were African American, their mean gestational age was 30 weeks, and their mean birth weight was 1,336 g. A total of 38 subjects completed measurements at baseline, on day 8, and on day 15. Dr. Viscardi and her associates found that the La/Rh ratio decreased between day 1 and day 8 in 97% of subjects, but increased greater than .048 between day 8 and day 15 in 21% of subjects.

In addition, exclusively breast milk–fed infants were less likely than were formula-fed (with or without breast milk) infants to experience an increase in IP between day 8 and day 15 (11% vs. 50%, respectively; P =. 019). They also observed a trend toward the use of ceftriaxone and increased IP between day 8 and day 15 (50% vs. 16%; P = .094). No subject developed NEC of stage 2 or higher.

“The data demonstrate that the preterm intestine is ‘leaky’ at birth and barrier function improves over time in a gestational and postnatal age-dependent manner,” Dr. Viscardi concluded. “Exclusive breast milk feeding may prevent increases in IP related to the introduction of oral feeding.”

The National Center for Complementary and Alternative Medicine and the Gerber Foundation funded the study. Dr. Viscardi reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

SAN DIEGO – Gestational age and postnatal age dependent intestinal barrier maturation in preterm infants may be altered by feeding and antibiotic exposures, a study conducted at two centers showed.

Mature, healthy intestinal mucosa is lined by a monolayer of epithelial cells that forms tight junctions and acts as a selective barrier to bacteria and harmful toxins, Dr. Rose M. Viscardi said at the annual meeting of the Pediatric Academic Societies. Intestinal permeability (IP) defines the leakiness of the mucosal barrier, and previous studies suggest that preterm infants have increased IP at birth that matures over time.

According to Dr. Viscardi, professor of pediatrics at the University of Maryland, Baltimore, increased IP is a risk factor for necrotizing enterocolitis (NEC). IP is disturbed in the newborn, particularly in preterm infants, “because they’re exposed to antibiotics and often delivered by cesarean section,” she said. “This may alter the IP such that there is the potential for bacteria crossing through that paracellular pathway, leading to enhanced neutrophil recruitment and intense inflammatory response both locally in the intestines as well as systematically, leading to the development of NEC.”

Current methods of determining intestinal barrier function include measurements of lactulose (La) and rhamnose (Rh) in urine and plasma, as well as stool alpha 1 antitrypsin (A1AT), a 52-KD glycoprotein produced by the liver, intestinal macrophages, and mucous membrane cells. Dr. Viscardi and her associates set out to determine changes in IP measures by urinary La/Rh and stool A1AT in the first 2 weeks of life in neonates at 24-32 weeks gestational age. The secondary objective was to determine the effect of feeding practices and antibiotic exposure on the IP maturation process in the first 2 weeks of life in those same infants.

At two sites, the researchers enrolled 43 infants at 24-32 weeks gestational age who received 1 mL/kg La/Rh solution (8.6 g La plus 140 mg Rh/100 mL sterile water) administered enterally on study days 1, 8, and 15, with urine collected after 4 hours. The researchers collected .5 mL blood by heel stick 90-120 minutes post La/Rh for serum La/Rh, and stool within 8 hours of La/Rh dose for fecal A1AT and later microbiome analysis.

Of the 43 subjects, 23 (53%) were male, 23 (53%) were African American, their mean gestational age was 30 weeks, and their mean birth weight was 1,336 g. A total of 38 subjects completed measurements at baseline, on day 8, and on day 15. Dr. Viscardi and her associates found that the La/Rh ratio decreased between day 1 and day 8 in 97% of subjects, but increased greater than .048 between day 8 and day 15 in 21% of subjects.

In addition, exclusively breast milk–fed infants were less likely than were formula-fed (with or without breast milk) infants to experience an increase in IP between day 8 and day 15 (11% vs. 50%, respectively; P =. 019). They also observed a trend toward the use of ceftriaxone and increased IP between day 8 and day 15 (50% vs. 16%; P = .094). No subject developed NEC of stage 2 or higher.

“The data demonstrate that the preterm intestine is ‘leaky’ at birth and barrier function improves over time in a gestational and postnatal age-dependent manner,” Dr. Viscardi concluded. “Exclusive breast milk feeding may prevent increases in IP related to the introduction of oral feeding.”

The National Center for Complementary and Alternative Medicine and the Gerber Foundation funded the study. Dr. Viscardi reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

SAN DIEGO – Gestational age and postnatal age dependent intestinal barrier maturation in preterm infants may be altered by feeding and antibiotic exposures, a study conducted at two centers showed.

Mature, healthy intestinal mucosa is lined by a monolayer of epithelial cells that forms tight junctions and acts as a selective barrier to bacteria and harmful toxins, Dr. Rose M. Viscardi said at the annual meeting of the Pediatric Academic Societies. Intestinal permeability (IP) defines the leakiness of the mucosal barrier, and previous studies suggest that preterm infants have increased IP at birth that matures over time.

According to Dr. Viscardi, professor of pediatrics at the University of Maryland, Baltimore, increased IP is a risk factor for necrotizing enterocolitis (NEC). IP is disturbed in the newborn, particularly in preterm infants, “because they’re exposed to antibiotics and often delivered by cesarean section,” she said. “This may alter the IP such that there is the potential for bacteria crossing through that paracellular pathway, leading to enhanced neutrophil recruitment and intense inflammatory response both locally in the intestines as well as systematically, leading to the development of NEC.”

Current methods of determining intestinal barrier function include measurements of lactulose (La) and rhamnose (Rh) in urine and plasma, as well as stool alpha 1 antitrypsin (A1AT), a 52-KD glycoprotein produced by the liver, intestinal macrophages, and mucous membrane cells. Dr. Viscardi and her associates set out to determine changes in IP measures by urinary La/Rh and stool A1AT in the first 2 weeks of life in neonates at 24-32 weeks gestational age. The secondary objective was to determine the effect of feeding practices and antibiotic exposure on the IP maturation process in the first 2 weeks of life in those same infants.

At two sites, the researchers enrolled 43 infants at 24-32 weeks gestational age who received 1 mL/kg La/Rh solution (8.6 g La plus 140 mg Rh/100 mL sterile water) administered enterally on study days 1, 8, and 15, with urine collected after 4 hours. The researchers collected .5 mL blood by heel stick 90-120 minutes post La/Rh for serum La/Rh, and stool within 8 hours of La/Rh dose for fecal A1AT and later microbiome analysis.

Of the 43 subjects, 23 (53%) were male, 23 (53%) were African American, their mean gestational age was 30 weeks, and their mean birth weight was 1,336 g. A total of 38 subjects completed measurements at baseline, on day 8, and on day 15. Dr. Viscardi and her associates found that the La/Rh ratio decreased between day 1 and day 8 in 97% of subjects, but increased greater than .048 between day 8 and day 15 in 21% of subjects.

In addition, exclusively breast milk–fed infants were less likely than were formula-fed (with or without breast milk) infants to experience an increase in IP between day 8 and day 15 (11% vs. 50%, respectively; P =. 019). They also observed a trend toward the use of ceftriaxone and increased IP between day 8 and day 15 (50% vs. 16%; P = .094). No subject developed NEC of stage 2 or higher.

“The data demonstrate that the preterm intestine is ‘leaky’ at birth and barrier function improves over time in a gestational and postnatal age-dependent manner,” Dr. Viscardi concluded. “Exclusive breast milk feeding may prevent increases in IP related to the introduction of oral feeding.”

The National Center for Complementary and Alternative Medicine and the Gerber Foundation funded the study. Dr. Viscardi reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

SAN DIEGO – Teens with chronic illnesses who participated in a program that consisted of mind-body principles and peer support demonstrated statistically significant positive changes in physical and mental well-being, anger, tension, and stress, in a pilot study.

“Young people living with serious chronic illnesses must deal not only with the physical effects and uncomfortable symptoms of their conditions, but must also endure significant psychosocial effects,” Dr. Brittany Blockman said in an interview in advance of the annual meeting of the Pediatric Academic Societies. “As we learn more about the impact of stress not only on mental health but also physical health, it will be important to design interventions and programs that address this vital, yet sometimes intangible area of health.”

Mind-body medicine focuses on the ways in which emotional, mental, social, and spiritual factors can directly impact health, said Dr. Blockman, a resident physician for the University of California, San Francisco’s Pediatric Leadership for the Underserved program. “Mind-body skills can enhance an individual’s sense of control and have been demonstrated to lower sympathetic arousal, decrease anxiety, and improve mood. Some examples of these modalities include meditation, mindfulness practices, breath work, yoga, biofeedback, and guided imagery. There is a growing body of literature reporting the positive physical and psychological health benefits of mind-body group interventions in various adult populations living with chronic illnesses, including improvements in quality of life, mood, pain, stress, coping skills, disease progression, and mortality. However, there is limited research exploring similar mind-body and group support interventions in pediatric and adolescent populations.”

Dr. Blockman and her associates enrolled 10 teens aged 13-18 years with chronic illnesses, and their parents, to study the impact of Communitas, a novel program that provides mind-body skills and peer support. Teens and parents met in separate groups 10 times for 2 hours at a time. Each session consisted of meditation, a lesson on guided imagery or some other mind-body technique, an exercise, and group sharing. The National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale, the Profile of Mood States (POMS), the Brief COPE scale, the Mindfulness Attention Awareness Scale (MAAS), the Perceived Stress Scale, and the Resilience Scale were administered before and after the 10 sessions.

The majority of teens (80%) were female; they attended an average of 7.3 sessions. Illnesses represented included juvenile idiopathic arthritis, cerebral palsy, type 1 diabetes, cancer, muscular dystrophy, cystic fibrosis, lung disease, spinal cord injury, and Wegener’s granulomatosis. Of the nine parents who participated, 75% were female; they completed an average of 7.5 sessions.

When Dr. Blockman and her associates compared baseline teen responses with those immediately after the 10-session intervention, they observed statistically significant effects on a number of scales, including the physical well-being subscale of the NIH PROMIS Global Health Scale (a mean increase of 1.56; P = .047); the mental well-being subscale of the NIH PROMIS Global Health Scale (a mean increase of 2.33; P = .025); the anger subscale of the POMS (a mean decrease of .54; P = .039); the tension subscale of the POMS (a mean decrease of .78; P = .006); the distraction/disengagement subscale of the Brief Cope (a mean decrease of .84; P = .035); and the Perceived Stress Scale (a mean decrease of 3.89; P = .005). The results for adults are still being analyzed.

“I was surprised at how willing the adolescents were to participate in the intervention and how engaged they were in the practices that were taught,” Dr. Blockman said. “It is our hope that the results of this study are helpful in thinking about the types of innovative interventions that may be useful in treating, healing, and supporting adolescents living with chronic illness, as well as their family members.”

She acknowledged certain limitations of the study, including the small sample size and the fact that there was no comparison group. “In the future, we plan to test our intervention further in a controlled trial design study, with a larger sample size. Another limitation is we cannot easily evaluate whether our positive results were attributable to the intervention content or the supportive nature of the intervention group. Our qualitative data may help us in teasing this apart.”

Dr. Blockman reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

SAN DIEGO – Teens with chronic illnesses who participated in a program that consisted of mind-body principles and peer support demonstrated statistically significant positive changes in physical and mental well-being, anger, tension, and stress, in a pilot study.

“Young people living with serious chronic illnesses must deal not only with the physical effects and uncomfortable symptoms of their conditions, but must also endure significant psychosocial effects,” Dr. Brittany Blockman said in an interview in advance of the annual meeting of the Pediatric Academic Societies. “As we learn more about the impact of stress not only on mental health but also physical health, it will be important to design interventions and programs that address this vital, yet sometimes intangible area of health.”

Mind-body medicine focuses on the ways in which emotional, mental, social, and spiritual factors can directly impact health, said Dr. Blockman, a resident physician for the University of California, San Francisco’s Pediatric Leadership for the Underserved program. “Mind-body skills can enhance an individual’s sense of control and have been demonstrated to lower sympathetic arousal, decrease anxiety, and improve mood. Some examples of these modalities include meditation, mindfulness practices, breath work, yoga, biofeedback, and guided imagery. There is a growing body of literature reporting the positive physical and psychological health benefits of mind-body group interventions in various adult populations living with chronic illnesses, including improvements in quality of life, mood, pain, stress, coping skills, disease progression, and mortality. However, there is limited research exploring similar mind-body and group support interventions in pediatric and adolescent populations.”

Dr. Blockman and her associates enrolled 10 teens aged 13-18 years with chronic illnesses, and their parents, to study the impact of Communitas, a novel program that provides mind-body skills and peer support. Teens and parents met in separate groups 10 times for 2 hours at a time. Each session consisted of meditation, a lesson on guided imagery or some other mind-body technique, an exercise, and group sharing. The National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale, the Profile of Mood States (POMS), the Brief COPE scale, the Mindfulness Attention Awareness Scale (MAAS), the Perceived Stress Scale, and the Resilience Scale were administered before and after the 10 sessions.

The majority of teens (80%) were female; they attended an average of 7.3 sessions. Illnesses represented included juvenile idiopathic arthritis, cerebral palsy, type 1 diabetes, cancer, muscular dystrophy, cystic fibrosis, lung disease, spinal cord injury, and Wegener’s granulomatosis. Of the nine parents who participated, 75% were female; they completed an average of 7.5 sessions.

When Dr. Blockman and her associates compared baseline teen responses with those immediately after the 10-session intervention, they observed statistically significant effects on a number of scales, including the physical well-being subscale of the NIH PROMIS Global Health Scale (a mean increase of 1.56; P = .047); the mental well-being subscale of the NIH PROMIS Global Health Scale (a mean increase of 2.33; P = .025); the anger subscale of the POMS (a mean decrease of .54; P = .039); the tension subscale of the POMS (a mean decrease of .78; P = .006); the distraction/disengagement subscale of the Brief Cope (a mean decrease of .84; P = .035); and the Perceived Stress Scale (a mean decrease of 3.89; P = .005). The results for adults are still being analyzed.

“I was surprised at how willing the adolescents were to participate in the intervention and how engaged they were in the practices that were taught,” Dr. Blockman said. “It is our hope that the results of this study are helpful in thinking about the types of innovative interventions that may be useful in treating, healing, and supporting adolescents living with chronic illness, as well as their family members.”

She acknowledged certain limitations of the study, including the small sample size and the fact that there was no comparison group. “In the future, we plan to test our intervention further in a controlled trial design study, with a larger sample size. Another limitation is we cannot easily evaluate whether our positive results were attributable to the intervention content or the supportive nature of the intervention group. Our qualitative data may help us in teasing this apart.”

Dr. Blockman reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

SAN DIEGO – Teens with chronic illnesses who participated in a program that consisted of mind-body principles and peer support demonstrated statistically significant positive changes in physical and mental well-being, anger, tension, and stress, in a pilot study.

“Young people living with serious chronic illnesses must deal not only with the physical effects and uncomfortable symptoms of their conditions, but must also endure significant psychosocial effects,” Dr. Brittany Blockman said in an interview in advance of the annual meeting of the Pediatric Academic Societies. “As we learn more about the impact of stress not only on mental health but also physical health, it will be important to design interventions and programs that address this vital, yet sometimes intangible area of health.”

Mind-body medicine focuses on the ways in which emotional, mental, social, and spiritual factors can directly impact health, said Dr. Blockman, a resident physician for the University of California, San Francisco’s Pediatric Leadership for the Underserved program. “Mind-body skills can enhance an individual’s sense of control and have been demonstrated to lower sympathetic arousal, decrease anxiety, and improve mood. Some examples of these modalities include meditation, mindfulness practices, breath work, yoga, biofeedback, and guided imagery. There is a growing body of literature reporting the positive physical and psychological health benefits of mind-body group interventions in various adult populations living with chronic illnesses, including improvements in quality of life, mood, pain, stress, coping skills, disease progression, and mortality. However, there is limited research exploring similar mind-body and group support interventions in pediatric and adolescent populations.”

Dr. Blockman and her associates enrolled 10 teens aged 13-18 years with chronic illnesses, and their parents, to study the impact of Communitas, a novel program that provides mind-body skills and peer support. Teens and parents met in separate groups 10 times for 2 hours at a time. Each session consisted of meditation, a lesson on guided imagery or some other mind-body technique, an exercise, and group sharing. The National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale, the Profile of Mood States (POMS), the Brief COPE scale, the Mindfulness Attention Awareness Scale (MAAS), the Perceived Stress Scale, and the Resilience Scale were administered before and after the 10 sessions.

The majority of teens (80%) were female; they attended an average of 7.3 sessions. Illnesses represented included juvenile idiopathic arthritis, cerebral palsy, type 1 diabetes, cancer, muscular dystrophy, cystic fibrosis, lung disease, spinal cord injury, and Wegener’s granulomatosis. Of the nine parents who participated, 75% were female; they completed an average of 7.5 sessions.

When Dr. Blockman and her associates compared baseline teen responses with those immediately after the 10-session intervention, they observed statistically significant effects on a number of scales, including the physical well-being subscale of the NIH PROMIS Global Health Scale (a mean increase of 1.56; P = .047); the mental well-being subscale of the NIH PROMIS Global Health Scale (a mean increase of 2.33; P = .025); the anger subscale of the POMS (a mean decrease of .54; P = .039); the tension subscale of the POMS (a mean decrease of .78; P = .006); the distraction/disengagement subscale of the Brief Cope (a mean decrease of .84; P = .035); and the Perceived Stress Scale (a mean decrease of 3.89; P = .005). The results for adults are still being analyzed.

“I was surprised at how willing the adolescents were to participate in the intervention and how engaged they were in the practices that were taught,” Dr. Blockman said. “It is our hope that the results of this study are helpful in thinking about the types of innovative interventions that may be useful in treating, healing, and supporting adolescents living with chronic illness, as well as their family members.”

She acknowledged certain limitations of the study, including the small sample size and the fact that there was no comparison group. “In the future, we plan to test our intervention further in a controlled trial design study, with a larger sample size. Another limitation is we cannot easily evaluate whether our positive results were attributable to the intervention content or the supportive nature of the intervention group. Our qualitative data may help us in teasing this apart.”

Dr. Blockman reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

SAN DIEGO – Iron supplementation, especially in pregnancy, improved toddler communication and social behaviors at 18 months in a large Chinese study.

“Iron deficiency in infancy is associated with altered social and emotional development,” Ming Li, Ph.D., said at the annual meeting of the Pediatric Academic Societies. “Some randomized, controlled trials of iron supplementation in infancy show social and emotional benefits.”

In an effort to assess the effects of iron supplementation and maternal iron status on infant communication and social interaction, Dr. Li of Peking University First Hospital in Beijing, China, in collaboration with Dr. Betsy Lozoff and her associates at the University of Michigan, Ann Arbor, used the 23-item Modified Checklist for Autism in Toddlers (M-CHAT) in 993 children in rural China who were part of two linked randomized, controlled trials. Their mothers had been randomized 1:1 to iron (300 mg ferrous sulfate) plus folate (400 micrograms) or placebo plus folate in pregnancy. As infants, they were randomized 1:1 to iron (liquid iron protein succinylate, about 1 mg Fe/kg per day) or placebo from 6 weeks to 9 months. In all, the two trials yielded four groups of prenatal or postnatal iron: placebo/placebo, placebo/iron, iron/placebo, and iron/iron.

The researchers administered the M-CHAT at 18 months to assess behaviors related to communication and social-emotional functioning, including imitation, joint attention, pretend play, and social referencing. The major outcome was the number of M-CHAT items failed. The threshold was two or more failed of the tool’s six most discriminating items or three or more failed of all 23 M-CHAT items. Bivariate correlation was used to consider the relation with maternal iron status.

The mean age of mothers was 25 years, and 78% were primiparous. More than 98% of the infants were born at term; mean birth weight was 3.36 kg. Their weight-for-age Z score was .90 at 9 months, and .53 at 18 months. Anemia, iron deficiency, and iron deficiency anemia declined with prenatal supplementation, but the majority of mothers were still iron deficient at term.

Dr. Li reported that the number of failed M-CHAT items varied depending on iron supplementation group, and was highest for the placebo/placebo group (3.1) and lowest for the iron/iron group (2.8) (P = 0.04 for linear trend). Mother’s iron status at enrollment was not associated with number of failed M-CHAT items, but late pregnancy iron status was. Lower maternal hemoglobin and higher soluble transferrin receptor predicted a higher number of failed M-CHAT items (P= .01 and P= .02, respectively).

Dr. Li emphasized that the study’s randomized, controlled design supports causal inferences. “These are best considered as behaviors [that are impacted], rather than autistic spectrum disorders,” he said. “The results suggest that iron supplementation in pregnancy has more effect than in infancy, but the infancy dose was low (1 mg/kg per day) and the impact on iron status at 9 months was minimal. Still, the combination of iron supplementation in pregnancy and infancy provided the greatest benefit.”

The pregnancy randomized, controlled trial was funded by Vifor Pharma, Ltd. The infancy randomized controlled trial and all iron measures were supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development with the Office of Dietary Supplements. Dr. Li reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

SAN DIEGO – Iron supplementation, especially in pregnancy, improved toddler communication and social behaviors at 18 months in a large Chinese study.

“Iron deficiency in infancy is associated with altered social and emotional development,” Ming Li, Ph.D., said at the annual meeting of the Pediatric Academic Societies. “Some randomized, controlled trials of iron supplementation in infancy show social and emotional benefits.”

In an effort to assess the effects of iron supplementation and maternal iron status on infant communication and social interaction, Dr. Li of Peking University First Hospital in Beijing, China, in collaboration with Dr. Betsy Lozoff and her associates at the University of Michigan, Ann Arbor, used the 23-item Modified Checklist for Autism in Toddlers (M-CHAT) in 993 children in rural China who were part of two linked randomized, controlled trials. Their mothers had been randomized 1:1 to iron (300 mg ferrous sulfate) plus folate (400 micrograms) or placebo plus folate in pregnancy. As infants, they were randomized 1:1 to iron (liquid iron protein succinylate, about 1 mg Fe/kg per day) or placebo from 6 weeks to 9 months. In all, the two trials yielded four groups of prenatal or postnatal iron: placebo/placebo, placebo/iron, iron/placebo, and iron/iron.

The researchers administered the M-CHAT at 18 months to assess behaviors related to communication and social-emotional functioning, including imitation, joint attention, pretend play, and social referencing. The major outcome was the number of M-CHAT items failed. The threshold was two or more failed of the tool’s six most discriminating items or three or more failed of all 23 M-CHAT items. Bivariate correlation was used to consider the relation with maternal iron status.

The mean age of mothers was 25 years, and 78% were primiparous. More than 98% of the infants were born at term; mean birth weight was 3.36 kg. Their weight-for-age Z score was .90 at 9 months, and .53 at 18 months. Anemia, iron deficiency, and iron deficiency anemia declined with prenatal supplementation, but the majority of mothers were still iron deficient at term.

Dr. Li reported that the number of failed M-CHAT items varied depending on iron supplementation group, and was highest for the placebo/placebo group (3.1) and lowest for the iron/iron group (2.8) (P = 0.04 for linear trend). Mother’s iron status at enrollment was not associated with number of failed M-CHAT items, but late pregnancy iron status was. Lower maternal hemoglobin and higher soluble transferrin receptor predicted a higher number of failed M-CHAT items (P= .01 and P= .02, respectively).

Dr. Li emphasized that the study’s randomized, controlled design supports causal inferences. “These are best considered as behaviors [that are impacted], rather than autistic spectrum disorders,” he said. “The results suggest that iron supplementation in pregnancy has more effect than in infancy, but the infancy dose was low (1 mg/kg per day) and the impact on iron status at 9 months was minimal. Still, the combination of iron supplementation in pregnancy and infancy provided the greatest benefit.”

The pregnancy randomized, controlled trial was funded by Vifor Pharma, Ltd. The infancy randomized controlled trial and all iron measures were supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development with the Office of Dietary Supplements. Dr. Li reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

SAN DIEGO – Iron supplementation, especially in pregnancy, improved toddler communication and social behaviors at 18 months in a large Chinese study.

“Iron deficiency in infancy is associated with altered social and emotional development,” Ming Li, Ph.D., said at the annual meeting of the Pediatric Academic Societies. “Some randomized, controlled trials of iron supplementation in infancy show social and emotional benefits.”

In an effort to assess the effects of iron supplementation and maternal iron status on infant communication and social interaction, Dr. Li of Peking University First Hospital in Beijing, China, in collaboration with Dr. Betsy Lozoff and her associates at the University of Michigan, Ann Arbor, used the 23-item Modified Checklist for Autism in Toddlers (M-CHAT) in 993 children in rural China who were part of two linked randomized, controlled trials. Their mothers had been randomized 1:1 to iron (300 mg ferrous sulfate) plus folate (400 micrograms) or placebo plus folate in pregnancy. As infants, they were randomized 1:1 to iron (liquid iron protein succinylate, about 1 mg Fe/kg per day) or placebo from 6 weeks to 9 months. In all, the two trials yielded four groups of prenatal or postnatal iron: placebo/placebo, placebo/iron, iron/placebo, and iron/iron.

The researchers administered the M-CHAT at 18 months to assess behaviors related to communication and social-emotional functioning, including imitation, joint attention, pretend play, and social referencing. The major outcome was the number of M-CHAT items failed. The threshold was two or more failed of the tool’s six most discriminating items or three or more failed of all 23 M-CHAT items. Bivariate correlation was used to consider the relation with maternal iron status.

The mean age of mothers was 25 years, and 78% were primiparous. More than 98% of the infants were born at term; mean birth weight was 3.36 kg. Their weight-for-age Z score was .90 at 9 months, and .53 at 18 months. Anemia, iron deficiency, and iron deficiency anemia declined with prenatal supplementation, but the majority of mothers were still iron deficient at term.

Dr. Li reported that the number of failed M-CHAT items varied depending on iron supplementation group, and was highest for the placebo/placebo group (3.1) and lowest for the iron/iron group (2.8) (P = 0.04 for linear trend). Mother’s iron status at enrollment was not associated with number of failed M-CHAT items, but late pregnancy iron status was. Lower maternal hemoglobin and higher soluble transferrin receptor predicted a higher number of failed M-CHAT items (P= .01 and P= .02, respectively).

Dr. Li emphasized that the study’s randomized, controlled design supports causal inferences. “These are best considered as behaviors [that are impacted], rather than autistic spectrum disorders,” he said. “The results suggest that iron supplementation in pregnancy has more effect than in infancy, but the infancy dose was low (1 mg/kg per day) and the impact on iron status at 9 months was minimal. Still, the combination of iron supplementation in pregnancy and infancy provided the greatest benefit.”

The pregnancy randomized, controlled trial was funded by Vifor Pharma, Ltd. The infancy randomized controlled trial and all iron measures were supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development with the Office of Dietary Supplements. Dr. Li reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

SAN DIEGO – Initiation of a process improvement initiative helped to increase health risk screening during adolescent visits, results from a single-center study showed.

It also revealed challenges inherent in teaching residents about adolescent primary care.

“Adolescence is a peak period for risk-taking behaviors and the development of chronic physical and mental health conditions, which is why many professional organizations recommend that teenagers and young adults receive an annual preventive visit to receive counseling and screening around some of these issues,” lead study author Dr. Maya Kumar said at the annual meeting of the Pediatric Academic Societies. “Unfortunately there’s a growing body of evidence to suggest that most adolescents and young adults are not receiving this recommended preventive care.”

With the introduction of the Affordable Care Act, she continued, “we anticipated that more and more low-income youth would be starting to come to us once they were eligible to sign up for insurance and start receiving primary care. That led us to start asking ourselves the question: Do we have an adequate, comprehensive screening process in place to protect these vulnerable youth?”

At the Children’s Hospital Los Angeles Teen Health Center, where Dr. Kumar served as a fellow in adolescent medicine until 2014, the researchers set out to improve annual documented screening rates within 9 months to 90% or greater for each of four process measures chosen based on the American Academy of Pediatrics’ Bright Futures guidelines: health risk behaviors, sexually transmitted infections/HIV laboratory screening, tuberculosis risk assessment, and vaccine review. The Teen Health Center operates three types of clinics: one staffed by attending physicians, one staffed by fellows, and one staffed by residents. The office staff for all clinics includes one registered nurse, two medical assistants, and four administrative support staff.

“We do have an EMR [electronic medical record] although it does have limitations,” said Dr. Kumar. “If we want to give screening questionnaires to our patients, we have to do it on paper, and then the provider has to manually review it separately from the EMR. There is no way to tell from the EMR the last time the patient came in for a preventive visit. The only way you as a provider can know [that] is to manually comb through every visit they’ve had and look to see what was done.

“We also don’t have an automated system to notify patients when it’s time for their next annual preventive visit, and many of our patients don’t have their parents involved, so they’re unlikely to remember on their own, and we don’t have a consistent way to contact them and remind them.”

The baseline period was July 1 through Aug. 31, 2013, while the intervention period was Sept. 1, 2013, through March 31, 2014. At baseline, “we had a lot of room for improvement,” said Dr. Kumar, who is now an attending physician in adolescent medicine at the University of California, San Diego. “We were underscreening our sexually active youth. We were not looking for TB risk factors, and while we were doing well screening for some risk behaviors such as tobacco exposure, we were not doing so well with other behaviors like whether they wore a bicycle helmet or a seat belt.”

During the 9-month intervention period, the researchers conducted three tests of change based on Deming’s Plan-Do-Study-Act (PDSA) cycles, in which the interventions were developed from discussions in weekly faculty fellow meetings, monthly office business meetings, and discussions with rotating trainees. After each of the PDSA cycles, at least 20 charts from the practice were reviewed to track progress in the 30 days following the intervention.

“We identified a number of factors we felt were contributing to inadequate baseline screening rates, [including] office staff workload,” Dr. Kumar said. “Having only one nurse and two medical assistants to staff multiple clinics running at the same time made it impossible for them to participate in the screening process at baseline; we didn’t have a way to schedule an annual well visit; we did not have a formal TB risk assessment tool; we were stuck using paper questionnaires; and we got feedback from residents who told us when they started the rotation that they were unfamiliar with what was involved in adolescent primary care, because so few of them had been exposed to adolescents during their pediatric residencies.”

The researchers approached the clinic’s IT department to ask if changes to the EMR could be made, including a recall system for annual physicals and provider alerts for the last time a patient had preventive screening. “We were told that was not possible at that time,” Dr. Kumar said. “So we had to focus on key drivers that were within our control.”

The first PDSA cycle focused on cuing the providers to ensure that they were reviewing the paper questionnaire about adolescent health screening. “We asked our medical assistants to insert the paper questionnaire sideways into the patient folders to give the providers a visual cue to stop and review the documents during the visit,” she said. The second PDSA cycle consisted of the introduction of a TB risk assessment form and a well-adolescent visit “cheat sheet” that was distributed to pediatric residents in electronic and hard copy forms, while the third PDSA targeted residents more heavily by giving them a 1-hour lecture about adolescent primary care, and sending an e-mail reminder to rotating residents about necessary screening.

In general, there was an increase for all of the process measures from baseline to the end of the study period, but a certain amount of attrition occurred between PDSA cycles 2 and 3. For example, the TB assessment was 19% at baseline, 27% after PDSA cycle 1, 85% after PDSA cycle 2, and 50% after PDSA cycle 3; screening for sexual activity was 81% at baseline, 91% after PDSA cycle 1, 100% after cycle 2, and 95% after cycle 3; while vaccine review was 57% at baseline, 72% after PDSA cycle 1, 100% after cycle 2, and 80% after cycle 3.

“We managed to improve our screening rates overall for almost all of the measures we were looking at,” Dr. Kumar said. “There was a lot of buy-in and support behind this project from the patients, providers, administrators, and office staff. Considering that we were not allowed to make changes to our EMR, we got a lot of bang for our buck.”

The attrition in many of the process measures by PDSA cycle 3 “highlights the fundamental need we have for systemic solutions rather than relying on individuals to change their behavior,” Dr. Kumar said. “The residents responded positively to the interventions that were targeted towards them. Many indicated that their understanding of adolescent preventive care improved. But they also said it was a lot to learn in a 1-month rotation. The only way we’re going to create sustainable change is to focus on system-based solutions.”

She said that staff at Children’s Hospital Los Angeles Teen Health Center are “working to use these results as leverage to expand EMR functionality to include a recall system for annual physicals; to create provider alerts to inform the provider when the patients are due for their next annual screening; and electronic versions of the questionnaires that the patients can complete and have downloaded directly to the EMR,” she said. “We also recognize the importance of improving longitudinal teaching around adolescent health throughout pediatric residency programs, and not just during a 1-month rotation.”

Dr. Kumar reported having no relevant financial conflicts.

[email protected]


On Twitter @dougbrunk

SAN DIEGO – Initiation of a process improvement initiative helped to increase health risk screening during adolescent visits, results from a single-center study showed.

It also revealed challenges inherent in teaching residents about adolescent primary care.

“Adolescence is a peak period for risk-taking behaviors and the development of chronic physical and mental health conditions, which is why many professional organizations recommend that teenagers and young adults receive an annual preventive visit to receive counseling and screening around some of these issues,” lead study author Dr. Maya Kumar said at the annual meeting of the Pediatric Academic Societies. “Unfortunately there’s a growing body of evidence to suggest that most adolescents and young adults are not receiving this recommended preventive care.”

With the introduction of the Affordable Care Act, she continued, “we anticipated that more and more low-income youth would be starting to come to us once they were eligible to sign up for insurance and start receiving primary care. That led us to start asking ourselves the question: Do we have an adequate, comprehensive screening process in place to protect these vulnerable youth?”

At the Children’s Hospital Los Angeles Teen Health Center, where Dr. Kumar served as a fellow in adolescent medicine until 2014, the researchers set out to improve annual documented screening rates within 9 months to 90% or greater for each of four process measures chosen based on the American Academy of Pediatrics’ Bright Futures guidelines: health risk behaviors, sexually transmitted infections/HIV laboratory screening, tuberculosis risk assessment, and vaccine review. The Teen Health Center operates three types of clinics: one staffed by attending physicians, one staffed by fellows, and one staffed by residents. The office staff for all clinics includes one registered nurse, two medical assistants, and four administrative support staff.

“We do have an EMR [electronic medical record] although it does have limitations,” said Dr. Kumar. “If we want to give screening questionnaires to our patients, we have to do it on paper, and then the provider has to manually review it separately from the EMR. There is no way to tell from the EMR the last time the patient came in for a preventive visit. The only way you as a provider can know [that] is to manually comb through every visit they’ve had and look to see what was done.

“We also don’t have an automated system to notify patients when it’s time for their next annual preventive visit, and many of our patients don’t have their parents involved, so they’re unlikely to remember on their own, and we don’t have a consistent way to contact them and remind them.”

The baseline period was July 1 through Aug. 31, 2013, while the intervention period was Sept. 1, 2013, through March 31, 2014. At baseline, “we had a lot of room for improvement,” said Dr. Kumar, who is now an attending physician in adolescent medicine at the University of California, San Diego. “We were underscreening our sexually active youth. We were not looking for TB risk factors, and while we were doing well screening for some risk behaviors such as tobacco exposure, we were not doing so well with other behaviors like whether they wore a bicycle helmet or a seat belt.”

During the 9-month intervention period, the researchers conducted three tests of change based on Deming’s Plan-Do-Study-Act (PDSA) cycles, in which the interventions were developed from discussions in weekly faculty fellow meetings, monthly office business meetings, and discussions with rotating trainees. After each of the PDSA cycles, at least 20 charts from the practice were reviewed to track progress in the 30 days following the intervention.

“We identified a number of factors we felt were contributing to inadequate baseline screening rates, [including] office staff workload,” Dr. Kumar said. “Having only one nurse and two medical assistants to staff multiple clinics running at the same time made it impossible for them to participate in the screening process at baseline; we didn’t have a way to schedule an annual well visit; we did not have a formal TB risk assessment tool; we were stuck using paper questionnaires; and we got feedback from residents who told us when they started the rotation that they were unfamiliar with what was involved in adolescent primary care, because so few of them had been exposed to adolescents during their pediatric residencies.”

The researchers approached the clinic’s IT department to ask if changes to the EMR could be made, including a recall system for annual physicals and provider alerts for the last time a patient had preventive screening. “We were told that was not possible at that time,” Dr. Kumar said. “So we had to focus on key drivers that were within our control.”

The first PDSA cycle focused on cuing the providers to ensure that they were reviewing the paper questionnaire about adolescent health screening. “We asked our medical assistants to insert the paper questionnaire sideways into the patient folders to give the providers a visual cue to stop and review the documents during the visit,” she said. The second PDSA cycle consisted of the introduction of a TB risk assessment form and a well-adolescent visit “cheat sheet” that was distributed to pediatric residents in electronic and hard copy forms, while the third PDSA targeted residents more heavily by giving them a 1-hour lecture about adolescent primary care, and sending an e-mail reminder to rotating residents about necessary screening.

In general, there was an increase for all of the process measures from baseline to the end of the study period, but a certain amount of attrition occurred between PDSA cycles 2 and 3. For example, the TB assessment was 19% at baseline, 27% after PDSA cycle 1, 85% after PDSA cycle 2, and 50% after PDSA cycle 3; screening for sexual activity was 81% at baseline, 91% after PDSA cycle 1, 100% after cycle 2, and 95% after cycle 3; while vaccine review was 57% at baseline, 72% after PDSA cycle 1, 100% after cycle 2, and 80% after cycle 3.

“We managed to improve our screening rates overall for almost all of the measures we were looking at,” Dr. Kumar said. “There was a lot of buy-in and support behind this project from the patients, providers, administrators, and office staff. Considering that we were not allowed to make changes to our EMR, we got a lot of bang for our buck.”

The attrition in many of the process measures by PDSA cycle 3 “highlights the fundamental need we have for systemic solutions rather than relying on individuals to change their behavior,” Dr. Kumar said. “The residents responded positively to the interventions that were targeted towards them. Many indicated that their understanding of adolescent preventive care improved. But they also said it was a lot to learn in a 1-month rotation. The only way we’re going to create sustainable change is to focus on system-based solutions.”

She said that staff at Children’s Hospital Los Angeles Teen Health Center are “working to use these results as leverage to expand EMR functionality to include a recall system for annual physicals; to create provider alerts to inform the provider when the patients are due for their next annual screening; and electronic versions of the questionnaires that the patients can complete and have downloaded directly to the EMR,” she said. “We also recognize the importance of improving longitudinal teaching around adolescent health throughout pediatric residency programs, and not just during a 1-month rotation.”

Dr. Kumar reported having no relevant financial conflicts.

[email protected]


On Twitter @dougbrunk

SAN DIEGO – Initiation of a process improvement initiative helped to increase health risk screening during adolescent visits, results from a single-center study showed.

It also revealed challenges inherent in teaching residents about adolescent primary care.

“Adolescence is a peak period for risk-taking behaviors and the development of chronic physical and mental health conditions, which is why many professional organizations recommend that teenagers and young adults receive an annual preventive visit to receive counseling and screening around some of these issues,” lead study author Dr. Maya Kumar said at the annual meeting of the Pediatric Academic Societies. “Unfortunately there’s a growing body of evidence to suggest that most adolescents and young adults are not receiving this recommended preventive care.”

With the introduction of the Affordable Care Act, she continued, “we anticipated that more and more low-income youth would be starting to come to us once they were eligible to sign up for insurance and start receiving primary care. That led us to start asking ourselves the question: Do we have an adequate, comprehensive screening process in place to protect these vulnerable youth?”

At the Children’s Hospital Los Angeles Teen Health Center, where Dr. Kumar served as a fellow in adolescent medicine until 2014, the researchers set out to improve annual documented screening rates within 9 months to 90% or greater for each of four process measures chosen based on the American Academy of Pediatrics’ Bright Futures guidelines: health risk behaviors, sexually transmitted infections/HIV laboratory screening, tuberculosis risk assessment, and vaccine review. The Teen Health Center operates three types of clinics: one staffed by attending physicians, one staffed by fellows, and one staffed by residents. The office staff for all clinics includes one registered nurse, two medical assistants, and four administrative support staff.

“We do have an EMR [electronic medical record] although it does have limitations,” said Dr. Kumar. “If we want to give screening questionnaires to our patients, we have to do it on paper, and then the provider has to manually review it separately from the EMR. There is no way to tell from the EMR the last time the patient came in for a preventive visit. The only way you as a provider can know [that] is to manually comb through every visit they’ve had and look to see what was done.

“We also don’t have an automated system to notify patients when it’s time for their next annual preventive visit, and many of our patients don’t have their parents involved, so they’re unlikely to remember on their own, and we don’t have a consistent way to contact them and remind them.”

The baseline period was July 1 through Aug. 31, 2013, while the intervention period was Sept. 1, 2013, through March 31, 2014. At baseline, “we had a lot of room for improvement,” said Dr. Kumar, who is now an attending physician in adolescent medicine at the University of California, San Diego. “We were underscreening our sexually active youth. We were not looking for TB risk factors, and while we were doing well screening for some risk behaviors such as tobacco exposure, we were not doing so well with other behaviors like whether they wore a bicycle helmet or a seat belt.”

During the 9-month intervention period, the researchers conducted three tests of change based on Deming’s Plan-Do-Study-Act (PDSA) cycles, in which the interventions were developed from discussions in weekly faculty fellow meetings, monthly office business meetings, and discussions with rotating trainees. After each of the PDSA cycles, at least 20 charts from the practice were reviewed to track progress in the 30 days following the intervention.

“We identified a number of factors we felt were contributing to inadequate baseline screening rates, [including] office staff workload,” Dr. Kumar said. “Having only one nurse and two medical assistants to staff multiple clinics running at the same time made it impossible for them to participate in the screening process at baseline; we didn’t have a way to schedule an annual well visit; we did not have a formal TB risk assessment tool; we were stuck using paper questionnaires; and we got feedback from residents who told us when they started the rotation that they were unfamiliar with what was involved in adolescent primary care, because so few of them had been exposed to adolescents during their pediatric residencies.”

The researchers approached the clinic’s IT department to ask if changes to the EMR could be made, including a recall system for annual physicals and provider alerts for the last time a patient had preventive screening. “We were told that was not possible at that time,” Dr. Kumar said. “So we had to focus on key drivers that were within our control.”

The first PDSA cycle focused on cuing the providers to ensure that they were reviewing the paper questionnaire about adolescent health screening. “We asked our medical assistants to insert the paper questionnaire sideways into the patient folders to give the providers a visual cue to stop and review the documents during the visit,” she said. The second PDSA cycle consisted of the introduction of a TB risk assessment form and a well-adolescent visit “cheat sheet” that was distributed to pediatric residents in electronic and hard copy forms, while the third PDSA targeted residents more heavily by giving them a 1-hour lecture about adolescent primary care, and sending an e-mail reminder to rotating residents about necessary screening.

In general, there was an increase for all of the process measures from baseline to the end of the study period, but a certain amount of attrition occurred between PDSA cycles 2 and 3. For example, the TB assessment was 19% at baseline, 27% after PDSA cycle 1, 85% after PDSA cycle 2, and 50% after PDSA cycle 3; screening for sexual activity was 81% at baseline, 91% after PDSA cycle 1, 100% after cycle 2, and 95% after cycle 3; while vaccine review was 57% at baseline, 72% after PDSA cycle 1, 100% after cycle 2, and 80% after cycle 3.

“We managed to improve our screening rates overall for almost all of the measures we were looking at,” Dr. Kumar said. “There was a lot of buy-in and support behind this project from the patients, providers, administrators, and office staff. Considering that we were not allowed to make changes to our EMR, we got a lot of bang for our buck.”

The attrition in many of the process measures by PDSA cycle 3 “highlights the fundamental need we have for systemic solutions rather than relying on individuals to change their behavior,” Dr. Kumar said. “The residents responded positively to the interventions that were targeted towards them. Many indicated that their understanding of adolescent preventive care improved. But they also said it was a lot to learn in a 1-month rotation. The only way we’re going to create sustainable change is to focus on system-based solutions.”

She said that staff at Children’s Hospital Los Angeles Teen Health Center are “working to use these results as leverage to expand EMR functionality to include a recall system for annual physicals; to create provider alerts to inform the provider when the patients are due for their next annual screening; and electronic versions of the questionnaires that the patients can complete and have downloaded directly to the EMR,” she said. “We also recognize the importance of improving longitudinal teaching around adolescent health throughout pediatric residency programs, and not just during a 1-month rotation.”

Dr. Kumar reported having no relevant financial conflicts.

[email protected]


On Twitter @dougbrunk

SAN DIEGO – More adolescents received the HPV vaccine when the vaccine was discussed in the context of other vaccines, and when the providers said they expected that the vaccine would be administered at the visit, results from a multisite study suggest.

Patients were more likely to get the HPV vaccine when it was discussed in context with other due vaccines (94% vs. 71%; P< .01) and when it was offered in the context of expectant provision, compared with all other communication types (100% vs. 76%; P< .01), researchers led by Dr. Paul M. Darden wrote in a poster abstract presented at the annual meeting of the Pediatric Academic Societies.

In a study conducted at six medical practices and two practice-based research networks, Dr. Darden, chief of the section of general and community pediatrics at the University of Oklahoma, and his associates set out to describe the types of recommendations for adolescent vaccines that nurses and clinicians give, how they vary with the type of vaccine, and whether the type of recommendation is associated with adolescent receipt of HPV vaccine.

To accomplish this, well visits where vaccines were due in patients aged 11-17 years were audiotaped and transcribed. Nurse and clinician texts were coded by validated coders. Clinician recommendations for Tdap, MCV4 and HPV were coded separately into one of five communication categories: none, passive (today you are due for ...), active (I really recommend ...), collaborative (today would you like to receive ...), and expectant provision (today you will get ...).

The researchers analyzed results from 106 patient visits (a range of 15-20 per practice), with 58 due for MCV4, 49 due for Tdap, and 101 due for HPV vaccine. Slightly more than half of the adolescents (53%) were 11 or 12 years of age, while the remainder ranged in age from 13 to 17 years. Nearly two-thirds (64%) were male, 38% were black, 28% were white, 27% were Hispanic, and the rest were from other ethnicities. A nurse assessment was audiotaped in 63 of the visits.

If the nurse mentioned that the patient was due for HPV vaccine, the patient was more likely to be vaccinated with HPV vaccine than if the nurse either did not address or only generally addressed the patient’s vaccination status (100% vs. 72%; P<i/>= .05). No communication for HPV was less common than for MCV and Tdap vaccines (6%, 14%, and 16%, respectively; P<i/>= .03.), while a collaborative recommendation (today would you like to receive …) was more common with the HPV vaccine (36% vs. 9% for MCV and 6% for Tdap; P< .01)

“The CDC recommends clinicians use a strong recommendation with patients for HPV vaccine delivery,” the researchers wrote. “Our research reflects that adolescents are more likely to receive vaccinations after any type of recommendation, but some appear to be more effective than others.” The results “can help inform the organization of pediatric vaccine delivery practices and the training of clinicians. Further research is needed in effective communication to identify the best way to discuss and deliver vaccines to adolescent patients.”

The study was funded by a grant through the Department of Health & Human Services, Health Resources and Services Administration, Maternal and Child Health Research Program. The researchers reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

SAN DIEGO – More adolescents received the HPV vaccine when the vaccine was discussed in the context of other vaccines, and when the providers said they expected that the vaccine would be administered at the visit, results from a multisite study suggest.

Patients were more likely to get the HPV vaccine when it was discussed in context with other due vaccines (94% vs. 71%; P< .01) and when it was offered in the context of expectant provision, compared with all other communication types (100% vs. 76%; P< .01), researchers led by Dr. Paul M. Darden wrote in a poster abstract presented at the annual meeting of the Pediatric Academic Societies.

In a study conducted at six medical practices and two practice-based research networks, Dr. Darden, chief of the section of general and community pediatrics at the University of Oklahoma, and his associates set out to describe the types of recommendations for adolescent vaccines that nurses and clinicians give, how they vary with the type of vaccine, and whether the type of recommendation is associated with adolescent receipt of HPV vaccine.

To accomplish this, well visits where vaccines were due in patients aged 11-17 years were audiotaped and transcribed. Nurse and clinician texts were coded by validated coders. Clinician recommendations for Tdap, MCV4 and HPV were coded separately into one of five communication categories: none, passive (today you are due for ...), active (I really recommend ...), collaborative (today would you like to receive ...), and expectant provision (today you will get ...).

The researchers analyzed results from 106 patient visits (a range of 15-20 per practice), with 58 due for MCV4, 49 due for Tdap, and 101 due for HPV vaccine. Slightly more than half of the adolescents (53%) were 11 or 12 years of age, while the remainder ranged in age from 13 to 17 years. Nearly two-thirds (64%) were male, 38% were black, 28% were white, 27% were Hispanic, and the rest were from other ethnicities. A nurse assessment was audiotaped in 63 of the visits.

If the nurse mentioned that the patient was due for HPV vaccine, the patient was more likely to be vaccinated with HPV vaccine than if the nurse either did not address or only generally addressed the patient’s vaccination status (100% vs. 72%; P<i/>= .05). No communication for HPV was less common than for MCV and Tdap vaccines (6%, 14%, and 16%, respectively; P<i/>= .03.), while a collaborative recommendation (today would you like to receive …) was more common with the HPV vaccine (36% vs. 9% for MCV and 6% for Tdap; P< .01)

“The CDC recommends clinicians use a strong recommendation with patients for HPV vaccine delivery,” the researchers wrote. “Our research reflects that adolescents are more likely to receive vaccinations after any type of recommendation, but some appear to be more effective than others.” The results “can help inform the organization of pediatric vaccine delivery practices and the training of clinicians. Further research is needed in effective communication to identify the best way to discuss and deliver vaccines to adolescent patients.”

The study was funded by a grant through the Department of Health & Human Services, Health Resources and Services Administration, Maternal and Child Health Research Program. The researchers reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

SAN DIEGO – More adolescents received the HPV vaccine when the vaccine was discussed in the context of other vaccines, and when the providers said they expected that the vaccine would be administered at the visit, results from a multisite study suggest.

Patients were more likely to get the HPV vaccine when it was discussed in context with other due vaccines (94% vs. 71%; P< .01) and when it was offered in the context of expectant provision, compared with all other communication types (100% vs. 76%; P< .01), researchers led by Dr. Paul M. Darden wrote in a poster abstract presented at the annual meeting of the Pediatric Academic Societies.

In a study conducted at six medical practices and two practice-based research networks, Dr. Darden, chief of the section of general and community pediatrics at the University of Oklahoma, and his associates set out to describe the types of recommendations for adolescent vaccines that nurses and clinicians give, how they vary with the type of vaccine, and whether the type of recommendation is associated with adolescent receipt of HPV vaccine.

To accomplish this, well visits where vaccines were due in patients aged 11-17 years were audiotaped and transcribed. Nurse and clinician texts were coded by validated coders. Clinician recommendations for Tdap, MCV4 and HPV were coded separately into one of five communication categories: none, passive (today you are due for ...), active (I really recommend ...), collaborative (today would you like to receive ...), and expectant provision (today you will get ...).

The researchers analyzed results from 106 patient visits (a range of 15-20 per practice), with 58 due for MCV4, 49 due for Tdap, and 101 due for HPV vaccine. Slightly more than half of the adolescents (53%) were 11 or 12 years of age, while the remainder ranged in age from 13 to 17 years. Nearly two-thirds (64%) were male, 38% were black, 28% were white, 27% were Hispanic, and the rest were from other ethnicities. A nurse assessment was audiotaped in 63 of the visits.

If the nurse mentioned that the patient was due for HPV vaccine, the patient was more likely to be vaccinated with HPV vaccine than if the nurse either did not address or only generally addressed the patient’s vaccination status (100% vs. 72%; P<i/>= .05). No communication for HPV was less common than for MCV and Tdap vaccines (6%, 14%, and 16%, respectively; P<i/>= .03.), while a collaborative recommendation (today would you like to receive …) was more common with the HPV vaccine (36% vs. 9% for MCV and 6% for Tdap; P< .01)

“The CDC recommends clinicians use a strong recommendation with patients for HPV vaccine delivery,” the researchers wrote. “Our research reflects that adolescents are more likely to receive vaccinations after any type of recommendation, but some appear to be more effective than others.” The results “can help inform the organization of pediatric vaccine delivery practices and the training of clinicians. Further research is needed in effective communication to identify the best way to discuss and deliver vaccines to adolescent patients.”

The study was funded by a grant through the Department of Health & Human Services, Health Resources and Services Administration, Maternal and Child Health Research Program. The researchers reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

SAN DIEGO – Adiponectin, a “healthy” hormone secreted from adipose tissue, was higher in adolescent females compared with males, and decreased as body weight increased, a longitudinal cohort analysis demonstrated.

“Low adiponectin levels are associated with metabolic risk, regardless of fat mass and sex,” lead study author Dr. Marcela Reyes said at the annual meeting of the Pediatric Academic Societies. “There is currently a gap in knowledge in factors that determine circulating adiponectin levels.”

In an effort to evaluate the role of infancy exposures (duration of breast feeding and weight-gain velocity) on adolescent adiponectin levels after taking into account gender and fat mass, Dr. Reyes and her associates studied a cohort of 584 normal–birth weight adolescents who were recruited at age 4 months for an iron deficiency preventive trial in Santiago, Chile from 1991 to 1996 and evaluated for cardiovascular risk 16 years later.

Dr. Reyes of the Institute of Nutrition and Food Technology at the University of Chile, Santiago, and her associates prospectively assessed breastfeeding from the age of 4 months and measured weight and height monthly. Adolescent outcomes included body mass index (BMI) z-scores, fat mass, and fasting serum adiponectin levels. The researchers used linear regression to model the effect of short breastfeeding (defined as breastfeeding for shorter than 180 days as the sole source of milk, as recommended by pediatricians) and weight gain in the first 6 months on adolescent adiponectin levels, after controlling for fat mass and gender.

The mean body weight at birth of the 584 adolescents was 3.5 kg, which increased to 8.0 kg at 6 months, with no change in the weight-for-age z-scores; 75% experienced a short exposure to breastfeeding. At age 16 years, their mean adiponectin level was 11.3 mcg/mL and differed by weight status and gender.

Specifically, the mean adiponectin levels among normal weight, overweight, and obese males were 11.06, 8.86, and 7.80 mcg/mL, respectively, while the mean adiponectin levels among normal weight, overweight, and obese females were 13.42, 12.12, and 9.04 mcg/mL, respectively. After the researchers controlled for gender and fat mass in adolescence, they found that shorter breastfeeding and change in weight-for-age z-score were associated with lower adolescent adiponectin levels (a 1.5 mcg/mL decrease in adiponectin levels for shorter breast feeding and a 0.7 mcg/mL decrease for every unit increase of weight-for-age z-score).

“Adiponectin levels are heterogeneous across sex and weight status,” Dr. Reyes concluded. “Earlier first bottle and higher weight gain during the first 6 months of age were associated with lower adiponectin levels in the adolescents.” She characterized the first 1,000 days of life as “a window of opportunity to try to prolong breastfeeding or to deal with rapid weight gain. This could help adolescents have healthier metabolic performance that may carry over into later life.”

The study was funded by the National Institutes of Health. Dr. Reyes reported having no relevant financial disclosures.

[email protected]

On Twitter @dougbrunk

SAN DIEGO – Adiponectin, a “healthy” hormone secreted from adipose tissue, was higher in adolescent females compared with males, and decreased as body weight increased, a longitudinal cohort analysis demonstrated.

“Low adiponectin levels are associated with metabolic risk, regardless of fat mass and sex,” lead study author Dr. Marcela Reyes said at the annual meeting of the Pediatric Academic Societies. “There is currently a gap in knowledge in factors that determine circulating adiponectin levels.”

In an effort to evaluate the role of infancy exposures (duration of breast feeding and weight-gain velocity) on adolescent adiponectin levels after taking into account gender and fat mass, Dr. Reyes and her associates studied a cohort of 584 normal–birth weight adolescents who were recruited at age 4 months for an iron deficiency preventive trial in Santiago, Chile from 1991 to 1996 and evaluated for cardiovascular risk 16 years later.

Dr. Reyes of the Institute of Nutrition and Food Technology at the University of Chile, Santiago, and her associates prospectively assessed breastfeeding from the age of 4 months and measured weight and height monthly. Adolescent outcomes included body mass index (BMI) z-scores, fat mass, and fasting serum adiponectin levels. The researchers used linear regression to model the effect of short breastfeeding (defined as breastfeeding for shorter than 180 days as the sole source of milk, as recommended by pediatricians) and weight gain in the first 6 months on adolescent adiponectin levels, after controlling for fat mass and gender.

The mean body weight at birth of the 584 adolescents was 3.5 kg, which increased to 8.0 kg at 6 months, with no change in the weight-for-age z-scores; 75% experienced a short exposure to breastfeeding. At age 16 years, their mean adiponectin level was 11.3 mcg/mL and differed by weight status and gender.

Specifically, the mean adiponectin levels among normal weight, overweight, and obese males were 11.06, 8.86, and 7.80 mcg/mL, respectively, while the mean adiponectin levels among normal weight, overweight, and obese females were 13.42, 12.12, and 9.04 mcg/mL, respectively. After the researchers controlled for gender and fat mass in adolescence, they found that shorter breastfeeding and change in weight-for-age z-score were associated with lower adolescent adiponectin levels (a 1.5 mcg/mL decrease in adiponectin levels for shorter breast feeding and a 0.7 mcg/mL decrease for every unit increase of weight-for-age z-score).

“Adiponectin levels are heterogeneous across sex and weight status,” Dr. Reyes concluded. “Earlier first bottle and higher weight gain during the first 6 months of age were associated with lower adiponectin levels in the adolescents.” She characterized the first 1,000 days of life as “a window of opportunity to try to prolong breastfeeding or to deal with rapid weight gain. This could help adolescents have healthier metabolic performance that may carry over into later life.”

The study was funded by the National Institutes of Health. Dr. Reyes reported having no relevant financial disclosures.

[email protected]

On Twitter @dougbrunk

SAN DIEGO – Adiponectin, a “healthy” hormone secreted from adipose tissue, was higher in adolescent females compared with males, and decreased as body weight increased, a longitudinal cohort analysis demonstrated.

“Low adiponectin levels are associated with metabolic risk, regardless of fat mass and sex,” lead study author Dr. Marcela Reyes said at the annual meeting of the Pediatric Academic Societies. “There is currently a gap in knowledge in factors that determine circulating adiponectin levels.”

In an effort to evaluate the role of infancy exposures (duration of breast feeding and weight-gain velocity) on adolescent adiponectin levels after taking into account gender and fat mass, Dr. Reyes and her associates studied a cohort of 584 normal–birth weight adolescents who were recruited at age 4 months for an iron deficiency preventive trial in Santiago, Chile from 1991 to 1996 and evaluated for cardiovascular risk 16 years later.

Dr. Reyes of the Institute of Nutrition and Food Technology at the University of Chile, Santiago, and her associates prospectively assessed breastfeeding from the age of 4 months and measured weight and height monthly. Adolescent outcomes included body mass index (BMI) z-scores, fat mass, and fasting serum adiponectin levels. The researchers used linear regression to model the effect of short breastfeeding (defined as breastfeeding for shorter than 180 days as the sole source of milk, as recommended by pediatricians) and weight gain in the first 6 months on adolescent adiponectin levels, after controlling for fat mass and gender.

The mean body weight at birth of the 584 adolescents was 3.5 kg, which increased to 8.0 kg at 6 months, with no change in the weight-for-age z-scores; 75% experienced a short exposure to breastfeeding. At age 16 years, their mean adiponectin level was 11.3 mcg/mL and differed by weight status and gender.

Specifically, the mean adiponectin levels among normal weight, overweight, and obese males were 11.06, 8.86, and 7.80 mcg/mL, respectively, while the mean adiponectin levels among normal weight, overweight, and obese females were 13.42, 12.12, and 9.04 mcg/mL, respectively. After the researchers controlled for gender and fat mass in adolescence, they found that shorter breastfeeding and change in weight-for-age z-score were associated with lower adolescent adiponectin levels (a 1.5 mcg/mL decrease in adiponectin levels for shorter breast feeding and a 0.7 mcg/mL decrease for every unit increase of weight-for-age z-score).

“Adiponectin levels are heterogeneous across sex and weight status,” Dr. Reyes concluded. “Earlier first bottle and higher weight gain during the first 6 months of age were associated with lower adiponectin levels in the adolescents.” She characterized the first 1,000 days of life as “a window of opportunity to try to prolong breastfeeding or to deal with rapid weight gain. This could help adolescents have healthier metabolic performance that may carry over into later life.”

The study was funded by the National Institutes of Health. Dr. Reyes reported having no relevant financial disclosures.

[email protected]

On Twitter @dougbrunk