The BREATHE Study: Bronchiolitis Recovery and Use of HEPA Filters

Study Summary: Lay Summary for Participant Families

The BREATHE Study: Bronchiolitis Recovery and Use of HEPA Filters

Author(s): The BREATHE Study Team

Why was this study conducted?

Bronchiolitis is an infection that affects the airways of a child. Babies with bronchiolitis may need hospital treatment. These babies may still have breathing problems, such as coughing and wheezing, after they go home.

Many things can affect a person’s ability to breathe. One of those things is the level of very small particles in the air. These particles are called PM2.5, which are particulate matter that is less than 2.5 micrometers across. That size is smaller than the size of most pollen and mold. The level of these very small particles in the air in someone’s home can be lowered by special air filters called high efficiency particulate air (HEPA) filters.

The BREATHE study was done to find out if HEPA filters used in a baby’s house can help them breathe better than if no filter is used in their house. Specifically, the study looked at how many days infants, who previously had bronchiolitis, had specific breathing problems such as coughing, wheezing, or other breathing problems.

What was done?

Babies chosen for this study were less than 12 months old and had been hospitalized for bronchiolitis for the first time. Babies were selected from 17 hospitals, each in a different state. A total of 228 families were given either 2 HEPA units or 2 control units (identical units but with filters removed). One unit was to be used in the baby’s sleep space and the other unit in a common room of the home. Families did not know which types of units they were given. Air quality monitors measured the level of very small particles (PM2.5) in their homes. Families reported the number of days that their babies had breathing troubles. These reports were done weekly for 6 months. At the end of the study, families learned whether they had been using HEPA units or control units. All families were then given new HEPA filters. They also received individual reports about the PM2.5 levels in their home.

What was found?

The number of days babies had breathing problems were counted. The number of problem days for the babies living in homes with HEPA filters were compared to the number of problem days for the babies living in homes that had control units. Generally, babies in homes with working HEPA units had fewer breathing problems than babies in homes with the control units. Babies in homes with HEPA units had an average of 5 fewer days with breathing problems than did babies in homes with the control units. However, because the difference between the 2 groups is quite small, it is not clear if the breathing improvement was related to HEPA filter use or due to chance. This does not mean that the HEPA filters were not useful. It only means that it could not be proven with this study.

Compared to those with control units, babies who had HEPA filter units in their home had a 9% lower chance of unscheduled healthcare visits, such as hospitalizations, emergency room visits, and doctor’s office visits for breathing problems, but the difference between the 2 groups is small and may be due to chance. Babies who had HEPA filter units running most of the time during the study had a 25% lower chance of unscheduled doctor’s office visits for breathing problems.

On average, homes with working HEPA units had average common room PM2.5 equal to 11 micrograms per cubic meter (μg/m3). On average, levels were higher in the common room of homes with control units (15 μg/m3). The difference was even bigger in the infant’s sleep space. On average, homes with HEPA units had sleep space PM2.5 equal to 11 μg/m3. On average, homes with control units had sleep space PM2.5 equal to 21 μg/m3.

What do the results mean?

Filtering air with a HEPA unit may help infants who have been in the hospital for bronchiolitis. Infants in houses with HEPA units may have fewer days of breathing trouble than infants in houses without HEPA units. However, we would need to do a larger study to know for sure.

Who sponsored the study?

This research was supported by the Environmental influences on Child Health Outcomes (ECHO) program, the Office of the Director, National Institutes of Health.

Appreciation

The authors appreciate the children and families whose participation made the research possible.

The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Lay Summary for the BREATHE Study (for participant distribution)
cIRB # 274137 V-01 (27-October-2025)

Influence of Eat, Sleep, and Console on Infants Pharmacologically Treated for Opioid Withdrawal: A Post Hoc Subgroup Analysis of the ESC-NOW Randomized Clinical Trial

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Influence of Eat, Sleep, and Console on Infants Pharmacologically Treated for Opioid Withdrawal: A Post Hoc Subgroup Analysis of the ESC-NOW Randomized Clinical Trial

Author(s): Lori A. Devlin, Zhuopei Hu, Stephanie L. Merhar, et al.

Why was this study conducted?

This secondary analysis of infants enrolled in the Eating, Sleeping and Consoling for Neonatal Opioid Withdrawal (ESC-NOW) trial, which was conducted at 26 hospitals across the U.S., focused specifically on infants who received opioid treatment for NOWS after birth. The analysis was conducted to identify whether the ESC care approach decreased total postnatal opioid exposure when compared to sites’ usual care practices, which included the use of the Finnegan Neonatal Abstinence Scoring Tool (FNAST).

What was done?

The authors analyzed data from 463 infants who were enrolled in the ESC-NOW trial. All infants were born at 36 weeks’ gestation or later and received pharmacologic treatment for NOWS after birth. Three hundred and twenty infants were assessed and managed for NOWS with usual care, and 143 infants were assessed and managed with the ESC care approach.

What was found?

In this subgroup analysis, the authors found that total postnatal opioid exposure was substantially less for infants who were assessed and managed with the ESC care approach when compared to usual care.

The absolute mean difference in total opioid exposure was 4.1 morphine milligram equivalents (MME)/kilogram (kg) less for infants in the ESC group when compared to the usual care group (4.8 vs. 8.9 MME/kg respectively). Infants in the ESC group also received an average of 48.7 fewer opioid doses than those in the usual care group (67.5 vs. 116.1 doses respectively). In addition, the mean length of opioid treatment was 6.3 days less in the ESC group than in the usual care group (11.8 vs. 18.1 days respectively), and the mean length of hospital stay was 6.2 days less in the ESC group than in the usual care group.

The authors also found that the mean time from birth to the initiation of pharmacologic care was 22.4 hours longer in the ESC group than in the usual care group (75.4 vs. 53.0 hours respectively), but there was no difference in the mean peak opioid dose between groups.

What do the results mean?

Infants who were assessed and managed with the ESC care approach received less opioid medication for the treatment of NOWS after birth when compared to those who were assessed and managed with usual care, including the FNAST.
Infants assessed and managed with the ESC care approach also had fewer days of opioid treatment and a shorter length of hospital stay when compared to usual care.
The time from birth to the initiation of opioid treatment was longer in infants who were assessed and managed with the ESC care approach, but there was no difference in the peak dose of opioid medication, which suggests that the ESC care approach aptly assesses and supports acute opioid withdrawal.

Who sponsored this study?

This clinical trial is a collaboration between the NIH Environmental influences on Child Health Outcomes (ECHO) Program and the NIH’s Eunice Kennedy Shriver Institute of Child Health and Human Development (NICHD), funded through the NIH Helping to End Addiction Long-term® Initiative (HEAL).

Where can I learn more?

Access the full journal article, titled “Influence of Eat, Sleep, and Console on Infants Pharmacologically Treated for Opioid Withdrawal: A Post Hoc Subgroup Analysis of the ESC-NOW Randomized Clinical Trial,” in JAMA Pediatrics.

The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

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Influence of Eat, Sleep, and Console on Infants Pharmacologically Treated for Opioid Withdrawal: A Post Hoc Subgroup Analysis of the ESC-NOW Randomized Clinical Trial

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“Eat, Sleep, Console” approach shown to be more effective in caring for newborns with neonatal opioid withdrawal syndrome

Authors: Leslie Young, Lori Devlin, Stephanie Merhar, et al.

How does prenatal opioid exposure affect child outcomes?

Author(s): Elisabeth Conradt, Sheila Crowell and Barry Lester

Understanding characteristics associated with opioid use during pregnancy

Authors: Ruby H.N. Nguyen, Monica McGrath, et al.

Phenobarbital and Clonidine as Secondary Medications for Neonatal Opioid Withdrawal Syndrome

Author(s): Stephanie Merhar, Songthip Ounpraseuth, Lori Devlin, et al.

Site-Level Variation in the Characteristics and Care of Infants with Neonatal Opioid Withdrawal

Author(s): Leslie Young, Zhuopei Hu, Robert Annett, et al.

The ACT NOW Clinical Practice Survey: Gaps in the Care of Infants With Neonatal Opioid Withdrawal Syndrome

Author(s): Jessica Snowden, Akshatha, Robert Annett, et al.

Can People Living in Rural Areas Accurately Measure Their Height and Weight at Home?

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Can People Living in Rural Areas Accurately Measure Their Height and Weight at Home?

Study title: Validation of remote height and weight assessment in a rural randomized pediatric clinical trial in primary care settings

Author(s): E (Alice) Zhang, Ann M. Davis, Elizabeth Yakes Jimenez, Brittany Lancaster, Monica Serrano-Gonzalez, Di Chang, Jeannette Lee, Jin-Shei Lai, Lee Pyles, Timothy VanWagoner, Paul Darden

Why was this study conducted?

Children living in rural areas have a greater risk for overweight. It may also be hard for them to join weight management programs or studies that require in-person visits. This study compared the accuracy of at-home height and weight measurements to those taken in person at a clinic.

What was done?

A total of 33 parent/child pairs took part in the study; the children were 6-11 years old. We gave each pair a digital bathroom scale, a tape measure, and instructions on measuring height and weight. Then, we guided them as they took their in-home measurements through a video call. The pairs also came to the clinic for their in-person measurements. Then, we compared the at-home and in-person measurements.

What was found?

There were no significant differences in the overall height and weight measurements taken at home compared to those taken in person at the clinic. However, some individual heights and weights differed significantly between at-home and in-person measurements. Age, race, ethnicity, parent education level, household income, and zip code were not significant predictors of at-home and in-person measurement comparisons.

What do the results mean?

It is possible to use everyday tools and technology to measure the weight and height of children living in rural areas. However, using these tools might reduce the accuracy of the measurements. Researchers and clinicians need to decide how accurate they need measurements to be before using these tools in the home.

Who sponsored the study?

This research was supported by the Environmental Influences on Child Health Outcomes (ECHO) program, the office of the Director, National Institutes of Health.

Appreciation

The researchers thank the wonderful families who made this work possible. We also thank Drs. Rebecca Romine and Kandace Fleming from the Life Span Institute, University of Kansas, for their input on data interpretation.

You may learn more about this publication here: https://www.nature.com/articles/s41598-023-50790-1

The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Published: January 3, 2024

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Can People Living in Rural Areas Accurately Measure Their Height and Weight at Home?

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General health and life satisfaction in children with chronic illness

Author(s): Courtney K. Blackwell, et al

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Authors: Izzuddin Aris, et al.

A Qualitative Exploration of COVID-19 Vaccine Hesitancy Among Parents

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A Qualitative Exploration of COVID-19 Vaccine Hesitancy Among Parents

Authors: Aubree Honcoop, James R Roberts, Boyd Davis, Charlene Pope, Erin Dawley, Russell McCulloh, Maryam Y Garza, Melody L Greer, Jessica Snowden, Linda Y Fu, Heather Young, Walter Dehority, Paul Enlow, Delma-Jean Watts, Katie Queen, Lisa Costello, Zain Alamarat, Paul M Darden

Why was this study conducted?

Research has shown that the COVID-19 vaccine is safe and effective at protecting children from severe COVID-19 disease. However, some parents have not yet vaccinated their children. Fewer children from a rural, Spanish-speaking, or Black backgrounds have received the vaccine than others.[i] We wanted to find out what parents from these groups think about the vaccine for their children. We interviewed parents about their concerns to learn how to address them and build their confidence in the vaccines.

What was done?

We selected 36 parents who lived in rural areas, spoke Spanish, and/or identified as Black. We only included parents with one or more unvaccinated children. We spoke with them about their thoughts for or against the COVID-19 vaccine.

What was found?

Many parents, whether they were for, against, or unsure about the COVID-19 vaccine, reported that they would listen to their doctor for vaccine information. Some parents wanted to know how well the vaccine protects children. Some parents also considered their child’s preferences for getting the vaccine. Others were concerned about the vaccine causing side effects or impacting health conditions such as asthma.

What do the results mean?

These results suggest what topics scientists might include in a mobile app designed to inform parents about the COVID-19 vaccine. However, this information was from a small number of parents and may not apply to people from other backgrounds.

Who sponsored this study?

This research was supported by the Environmental influences on Child Health Outcomes (ECHO) program in the Office of the Director, National Institutes of Health (NIH).

Appreciation:

Most of all, we thank the parents who took part in the study. We also thank the site coordinators, clinic staff, and ECHO ISPCTN Data Coordinating & Operations Center staff for their support.

You may learn more about this publication here: https://pubmed.ncbi.nlm.nih.gov/37867449/

To learn more about the COVID-19 vaccine for children, visit:

The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

______________________________________

[i] The National Institutes of Health (NIH) has identified individuals from rural, medically underserved, and migrant communities as high priorities for vaccination and vaccine communication efforts. This includes children living in rural areas, from Spanish-speaking households, or who identify as Black. For current data on COVID-19, including vaccination rates, please visit the CDC website.

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A Qualitative Exploration of COVID-19 Vaccine Hesitancy Among Parents

How Much Vitamin D do Children with Asthma and Increased Body Weight Need to Correct Low Vitamin D Levels?

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How much vitamin D do children with asthma and increased body weight need to correct low vitamin D levels?

Study title: Pharmacokinetics of Oral Vitamin D in Children with Obesity and Asthma

Author(s): Jason E. Lang, Rodrigo Gonzalez Ramirez, Stephen Balevic, Brian O’Sullivan, Scott Bickel, Christoph P. Hornik, J. Marc Majure, Saranya Venkatachalam, Jessica Snowden, Laura James

Why was this study conducted?

Among children with asthma, children who also have increased body weight for their height (body mass index (BMI) of ≥85 percentile) tend to have more severe asthma symptoms than their healthy weight peers. Children with asthma and increased body weight also tend to have lower vitamin D levels than other children. Helping children with asthma and increased body weight reach higher vitamin D levels may help their asthma symptoms by lowering inflammation in the lungs. However, there is not enough information on how much vitamin D children with asthma and increased body weight should take to safely raise their vitamin D levels.

What was done?

ECHO ISPCTN research teams in 15 states enrolled children ages 6‑18 years with asthma and increased body weight in a clinical trial. The children took vitamin D capsules for 16 weeks and gave blood samples every month so researchers could check their vitamin D levels. The goal of the study was to find a vitamin D dose that helped children raise their vitamin D levels in their blood to 40 ng/mL, a level that might lower inflammation.

There were two parts of the study. In the first part, children were split into four groups that each took one of four different doses of vitamin D to find a dose that raised children’s vitamin D levels over 16 weeks without causing side effects. All four dosing options were higher than what is usually recommended to raise vitamin D levels. Then, researchers compared the vitamin D dose from part 1 that raised vitamin D levels quickly and safely to the usually recommended daily vitamin D dose to confirm that the higher dose could safely help children reach vitamin D levels that may decrease inflammation. This study was approved by the Institutional Review Board and all participants consented to participate in the study.

What was found?

The first part of the study found that taking a 50,000 international units (IU) vitamin D dose on the first day of treatment and then an 8,000 IU vitamin D dose every day for 16 weeks was most effective at raising vitamin D levels safely. In the second part of the study, researchers confirmed that using this approach raised vitamin D levels in most children to the recommended level while avoiding undesired higher levels. In contrast, no children who followed the current standard-of-care dosing of 600 IU each day achieved the target vitamin D level sufficient to potentially reduce inflammation.

What do the results mean?

Most children with asthma and increased body weight who take vitamin D the vitamin D dose used in this study (50,000 IU vitamin D on day one, then 8,000 IU each day) can safely raise their vitamin D level in a short period of time. The newly determined dose is much greater than the typically recommended dose. This study shows how important it is that children and adolescents with increased body weight get enough vitamin D in their diet or in vitamin supplements every day since the higher the body weight, the faster vitamin D was processed and removed from the body. The results of this study may help children with asthma or other illnesses if having enough Vitamin D lowers inflammation.

Who sponsored the study?

This research was supported by the Environmental influences on Child Health Outcomes (ECHO) program, Office of The Director, National Institutes of Health.

Appreciation

All of the families in ECHO ISPCTN trials help study teams across the country learn more every day about how to bring rural and underserved families into research studies. This is critical to ensure that families that are not near large academic centers still get the benefits of research and that the “answers” research studies find are meaningful for children and families across all parts of the country, not just those who live in large cities.

You may learn more about this publication here: https://link.springer.com/article/10.1007/s40262-023-01285-9

The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Published: August 30, 2023

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How much vitamin D do children with asthma and increased body weight need to correct low vitamin D levels?

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What Are factors That Affect the Incidence Rate of Asthma With Recurrent Exacerbations in Children?

Authors: Rachel L. Miller; Christine C. Johnson, et al.

A Nationwide Study on How Childhood Asthma Relates to Obesity Development

Authors: Nikos Stratakis and Erika Garcia

General health and life satisfaction in children with chronic illness

Author(s): Courtney K. Blackwell, et al

ECHO Study Suggests Neighborhood Conditions Throughout Childhood May Shape Risk of Developing Asthma

Authors: Izzuddin Aris, et al.

“Eat, Sleep, Console” approach shown to be more effective in caring for newborns with neonatal opioid withdrawal syndrome

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“Eat, Sleep, Console” approach shown to be more effective in caring for newborns with neonatal opioid withdrawal syndrome

Author(s): Leslie Young, Lori Devlin, Stephanie Merhar, et al.

Who sponsored this study?

This clinical trial is a collaboration between the National Institutes of Health (NIH) Environmental influences on Child Health Outcomes (ECHO) Program and the NIH’s Eunice Kennedy Shriver Institute of Child Health and Human Development (NICHD), funded through the NIH Helping to End Addiction Long-term® Initiative (HEAL).

What were the study results?

Researchers found that the “Eat, Sleep, Console” (ESC) care approach is more effective for the treatment of infants with neonatal opioid withdrawal syndrome (NOWS) than usual approaches to care. ESC focuses on care without the use of medications, and includes holding, swaddling, and rocking the baby in a quiet, calm environment.

In this clinical trial, infants cared for with ESC were medically ready for discharge after an average of 8.2 days, whereas infants cared for with usual approaches were medically ready for discharge after 14.9 days. That means that babies were, on average, able to go home 6.7 days sooner. Newborns cared for with ESC were also 63% less likely to receive medication as part of their treatment (19.5% in the ESC group received opioid therapy, compared to 52% in the Finnegan Neonatal Abstinence Scoring Tool [FNAST] group). Safety outcomes at three months of age were similar between both groups.

What was the study's impact?

Newborns exposed to opioids before birth may develop symptoms of NOWS. These symptoms may include tremors, excessive crying and irritability, and problems with sleeping and feeding. In the United States, at least one newborn is diagnosed with NOWS every 24 minutes. There has not previously been strong evidence to support a standard approach to the care of babies with NOWS, and medical care for these babies has varied widely across hospitals.

This study gives hospitals an evidence-based approach to care for babies with NOWS. Compared with usual care using traditional scoring approaches, the ESC care approach substantially shortens the time infants spend in the hospital. The ESC approach has also been shown as safe as usual care approaches after discharge through early infancy.

Why was this study needed?

Hospitals have different approaches for caring for these babies. They often use FNAST to assess newborns with NOWS. The FNAST is an extensive scoring system that assesses signs of withdrawal in more than 20 areas. Concerns have been raised about its subjectivity and overestimation of the need for opioid medication.

The ESC care approach was developed about eight years ago and is growing in popularity in some nurseries, but this method had not previously been rigorously tested. ESC assessments are centered on an infant’s ability to eat, sleep and be consoled without the introduction of medications, and this approach keeps mother and baby together, empowering families to play a larger role in the care of their infants. However, the widespread adoption of ESC without solid evidence of its effectiveness and safety has raised concerns about potentially undertreating infants or discharging them too early. This study tested the extent to which ESC might be a better way to care for babies with NOWS.

Who was involved?

The study examined the hospital outcomes of a diverse group of 1,305 opioid-exposed infants from 26 hospitals across the U.S. The study is part of the Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Collaborative, which brings together two existing pediatric research networks: the NICHD Neonatal Research Network and the ECHO Program’s Institutional Development Award (IDeA) States Pediatric Clinical Trials Network (ISPCTN).

What happened during the study?

The researchers randomized 26 hospitals to transition from FNAST-based care to the ESC care approach at different times. They then evaluated each method based on how soon infants were ready to leave the hospital and whether infants were treated with opioid medication to manage their symptoms.

Footnote: Results reported here are for a single study. Other or future studies may provide new information or different results. You should not make changes to your healthcare without first consulting your healthcare professional.

What happens next?

The researchers will continue to follow up with a subset of the participating infants for two more years to see if the ESC approach has any effect on infant and family well-being.

Where can I learn more?

Access the full journal article, titled “Eat, sleep, console approach versus usual care for neonatal opioid withdrawal,” in the New England Journal of Medicine.

Learn more about this clinical trial and the NIH Helping to End Addiction Long-term^® Initiative on the NIH HEAL Initiative^® website.

The content is the responsibility of the authors and does not necessarily represent the official views of the NIH.

Access the associated article.

Published: April 30, 2023

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“Eat, Sleep, Console” approach shown to be more effective in caring for newborns with neonatal opioid withdrawal syndrome

Read Related Research Summaries

How does prenatal opioid exposure affect child outcomes?

Author(s): Elisabeth Conradt, Sheila Crowell and Barry Lester

Understanding characteristics associated with opioid use during pregnancy

Authors: Ruby H.N. Nguyen, Monica McGrath, et al.

Phenobarbital and Clonidine as Secondary Medications for Neonatal Opioid Withdrawal Syndrome

Author(s): Stephanie Merhar, Songthip Ounpraseuth, Lori Devlin, et al.

Site-Level Variation in the Characteristics and Care of Infants with Neonatal Opioid Withdrawal

Author(s): Leslie Young, Zhuopei Hu, Robert Annett, et al.

The ACT NOW Clinical Practice Survey: Gaps in the Care of Infants With Neonatal Opioid Withdrawal Syndrome

Author(s): Jessica Snowden, Akshatha, Robert Annett, et al.

Rural Family Satisfaction with Telehealth Delivery of an Intervention for Pediatric Obesity and Associated Family Characteristics

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Rural Family Satisfaction with Telehealth Delivery of an Intervention for Pediatric Obesity and Associated Family Characteristics

Author(s): Nguyen L, Phan TL, Falini L, Chang D, Cottrell L, Dawley E, Hockett CW, VanWagoner T, Darden PM, Davis AM

Why was this study conducted?

Childhood obesity is a serious health problem in the United States and affects more children from rural areas. Experts recommend treating children with obesity within family-based behavioral groups. However, rural areas often don’t have access to these programs. Telehealth is a way to deliver these programs to rural families, but few studies have looked at family satisfaction with behavioral programs delivered this way or who might benefit most from these visits. This study looked at how parents of children living in rural communities rated their experience with telehealth visits to help their child make healthy lifestyle changes, as well as family characteristics associated with satisfaction.

What was done?

A study was conducted with families of children aged 6 to 11 years with overweight or obesity living in rural areas. Half of the children received the telehealth program and a health newsletter, while the other half received only the health newsletter. After the study, parents of children who received the telehealth visits rated the visits in four areas:

The telehealth technology experience
The comfort and privacy they felt with telehealth
The speed and ease of getting care with telehealth
Their overall satisfaction with telehealth

What was found?

Parents were overall very satisfied with the telehealth visits noting they felt comfortable with the technology and satisfied with the privacy. Parents with lower education and income levels reported the highest levels of satisfaction. Race, ethnic group, and in-home internet access did not affect satisfaction ratings.

What do the results mean?

These results show that families from rural areas like telehealth visits and that telehealth might be a good way to increase access to treatment for children with overweight or obesity, especially among disadvantaged communities. There are still barriers to overcome, such as health literacy and access to broadband internet and devices. Larger studies are needed to better understand who might benefit most from telehealth.

Who sponsored the study?

This research was supported by the Environmental influences on Child Health Outcomes (ECHO) program, Office of The Director, National Institutes of Health.

Appreciation:

We sincerely appreciate the clinics, staff, children, and parents who participated in this study. The authors thank the Environmental influences on Child Health Outcomes (ECHO) program, the Office of the Director, National Institutes of Health, for supporting this research.

You may learn more about this publication here: https://www.liebertpub.com/doi/10.1089/chi.2022.0210

The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Published: April 10, 2023

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Rural Family Satisfaction with Telehealth Delivery of an Intervention for Pediatric Obesity and Associated Family Characteristics

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Conducting a Pediatric Randomized Clinical Trial During a Pandemic: A Shift to Virtual Procedures

Author(s): James Roberts, Sheva Chervinskiy, Russell McCulloh, et al.

Influences of Health Conditions on Children’s Overall Health and Life Satisfaction

Author(s): Julia Schuchard, et al.

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Author(s): Courtney K. Blackwell, et al

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The Influence of Opioid Use Disorder Medications During Pregnancy on the Severity of Neonatal Opioid Withdrawal Syndrome

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The Influence of Mediators on the Relationship Between Antenatal Opioid Agonist Exposure and the Severity of Neonatal Opioid Withdrawal Syndrome

Author(s): Lori A. Devlin, Zhuopei Hu, Songthip Ounpraseuth, Alan E. Simon, Robert D. Annett, Abhik Das, Janell F. Fuller, Rosemary D. Higgins, Stephanie L. Merhar, P. Brian Smith, Margaret M. Crawford, Lesley E. Cottrell, Adam J. Czynski, Sarah Newman, David A. Paul, Pablo J. Sánchez, Erin O. Semmens, M. Cody Smith, Bonny L. Whalen, Jessica N. Snowden, Leslie W. Young

Why was this study conducted?

Opioid use disorder is a treatable disease that can be managed with medicine for opioid use disorder (MOUD). This type of treatment is recommended for pregnant individuals by healthcare professionals to improve pregnancy and newborn outcomes.

Babies who were exposed to opioids during pregnancy may develop signs of neonatal opioid withdrawal syndrome (NOWS), including tremors; excessive crying and irritability; and problems with sleeping and feeding. This study looked at how MOUD use during pregnancy influenced the severity of NOWS symptoms.

What was done?

Data were collected from the medical records’ of 1294 opioid-exposed infants born at or cared for in 30 U.S. hospitals between July 2016 and June 2017. There were 859 infants exposed to MOUD (methadone or buprenorphine) and 435 infants exposed to opioids other than MOUD. We looked to see if infants needed medication to treat NOWS and how long they stayed in the hospital.

What was found?

The results suggest that exposure to MOUD (buprenorphine or methadone) during pregnancy increased the severity of NOWS. Infants exposed to MOUD were two times more likely to need an opioid medication to treat withdrawal. They also remained in the hospital 1.7 days longer than infants not exposed to MOUD. Some factors that reduced the severity of NOWS in infants treated with MOUD were adequate prenatal care, exposure to a single type of opioid, and not being exposed to other mood-changing drugs simultaneously. These factors also decreased the likelihood that infant would need opioid medicine to treat their NOWS symptoms and shortened their hospital stay. Infants exposed to buprenorphine instead of methadone had a shorter length of hospital stay and needed less treatment with opioid medication.

What do the results mean?

Medical experts recommend that pregnant women with an opioid use disorder use MOUD for healthier pregnancies. MOUD can reduce the chances of pregnancy loss, premature birth, infection, and poor growth of the infant. However, using MOUD may be related to increases in the severity of NOWS. Learning more about how MOUD affects the severity of NOWS can help doctors improve the health of mothers using MOUD and their babies. These results also suggest that adequate prenatal care can help improve pregnancy and birth outcomes, and highlight the importance of identifying barriers to receiving sufficient prenatal care as an opportunity to improve infant outcomes.

Who sponsored the study?

This research was supported by the Environmental Influences on Child Health Outcomes Program, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Center for Advancing Translational Sciences, and the National Institutes of Health.

Appreciation:

We deeply appreciate the doctors, nurses, and hospitals that participated in the study and helped identify and extract information from the required medical records. Their enthusiastic collaboration made this study possible.

You may learn more about this publication here: https://link.springer.com/article/10.1007/s10995-022-03521-3

The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Published: March 11, 2023

Download this summary

The Influence of Mediators on the Relationship Between Antenatal Opioid Agonist Exposure and the Severity of Neonatal Opioid Withdrawal Syndrome

Read Related Research Summaries

“Eat, Sleep, Console” approach shown to be more effective in caring for newborns with neonatal opioid withdrawal syndrome

Author(s): Leslie Young, Lori Devlin, Stephanie Merhar, et al.

How does prenatal opioid exposure affect child outcomes?

Author(s): Elisabeth Conradt, Sheila Crowell and Barry Lester

Understanding characteristics associated with opioid use during pregnancy

Authors: Ruby H.N. Nguyen, Monica McGrath, et al.

Phenobarbital and Clonidine as Secondary Medications for Neonatal Opioid Withdrawal Syndrome

Author(s): Stephanie Merhar, Songthip Ounpraseuth, Lori Devlin, et al.

Site-Level Variation in the Characteristics and Care of Infants with Neonatal Opioid Withdrawal

Author(s): Leslie Young, Zhuopei Hu, Robert Annett, et al.

The ACT NOW Clinical Practice Survey: Gaps in the Care of Infants With Neonatal Opioid Withdrawal Syndrome

Author(s): Jessica Snowden, Akshatha, Robert Annett, et al.

Conducting a Pediatric Randomized Clinical Trial During a Pandemic: A Shift to Virtual Procedures

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Conducting a Pediatric Randomized Clinical Trial During a Pandemic: A Shift to Virtual Procedures

Authors: James Roberts, Sheva Chervinskiy, Russell McCulloh, Jessica Snowden, Paul Darden, Thao-Ly Phan, Erin Dawley, Victoria Reynolds, Crystal Lim, Lee Pyles, DeAnn Hubberd, Jaime Baldner, Lora Lawrence, Ann Davis

Who sponsored this study?

This research was supported by the Environmental influences on Child Health Outcomes (ECHO) program, the Office of the Director, National Institutes of Health.

What was done?

The study's goal was to enroll 128 children aged 6 to 12 years old and one parent at four rural clinics over 10 weeks. However, the trial was paused after 6 weeks due to COVID-19. Over the next 12 weeks, the trial resumed using virtual visits where investigators completed enrollment, obtained informed consent, and assessed height and weight of children. Because all study activity was virtual, digital scales and height measurement equipment were shipped to participants' homes, and a second virtual visit was conducted to monitor these measurements. Some participants who did not have internet and needed support for virtual visits received internet-enabled tablets.

What was found?

When the trial was paused, 42 patients had been enrolled. When the trial resumed virtually, 28 of the 42 continued in the trial, and an additional 89 new participants were enrolled for a total of 117 children. Flexibility was key to solving problems and continuing to enroll and retain participants.

The investigators discovered the challenges and benefits of conducting a virtual trial of this nature. Some challenges to conducting a virtual trial include unreliable equipment delivery, unreturned study equipment, slow Internet speeds and/or poor Internet access in rural areas, and the added costs of buying and shipping equipment and mailing other study materials. However, the benefits of a virtual trial included the ability to conduct study visits at other times of the day, including evenings and weekends. For example, research staff could conduct study visits at any time of the day, and study-related travel was limited.

What do the results mean?

The lessons learned from this trial can be applied by any study team recruiting participants from rural areas for a clinical trial. These include:

Virtual visits and procedures enable successful recruitment and retention of participants from rural areas.
Research teams must be agile, flexible, and willing to adapt study procedures to meet clinic resources and unanticipated situations.
While there are considerable additional expenses for buying and shipping study equipment to participants, these costs may be offset by decreased travel to and from rural areas by study staff.

Why was this study conducted?

In the United States, children living in rural areas have higher rates of being overweight. Unfortunately, children from rural areas seldom participate in clinical research trials. A clinical research trial on changing lifestyle behaviors in rural children who were overweight started in early 2020 but, due to the COVID-19 pandemic, had to switch to virtual procedures instead of in-person visits. Sharing the solutions to problems faced and the lessons learned in completing this trial may help other research teams recruit participants living in rural areas.

Appreciation:

The authors appreciate the children, families, and clinics whose participation made the research possible.

You can read the full publication here: https://doi.org/10.1017/cts.2022.453

The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

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Conducting a Pediatric Randomized Clinical Trial During a Pandemic: A Shift to Virtual Procedures

Facilitators and Barriers to Pediatric Clinical Trial Recruitment and Retention in Rural and Community Settings: A Scoping Review of the Literature

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Facilitators and Barriers to Pediatric Clinical Trial Recruitment and Retention in Rural and Community Settings: A Scoping Review of the Literature

Author(s): Sara E. Watson, Paul Smith, Jessica Snowden, Vida Vaughn, Lesley Cottrell, Christi A. Madden, Alberta S. Kong, Russell McCulloh, Crystal Stack Lim, Megan Bledsoe, Karen Kowal, Mary McNally, Lisa Knight, Kelly Cowan, Elizabeth Yakes Jimenez

Who sponsored this study?

This research was supported by the Environmental influences on Child Health Outcomes (ECHO) program, Office of The Director, National Institutes of Health.

What was done?

The authors conducted a review of published research papers to determine what factors make it easier or harder for children to participate in clinical research studies in rural and community-based settings. The authors considered studies to have been conducted in a “community-based setting” if all activities occurred outside of a clinic or hospital. The team reviewed other published articles to determine what strategies other researchers had used to enroll children in studies and help them stay enrolled until the studies were completed. They then looked to see which strategies were most helpful.

What was found?

In this systematic review, there were few published studies that specifically describe useful strategies for enrolling children in rural settings into clinical trials or strategies to help them stay enrolled. Strategies that have been helpful include sending families visit reminders, building relationships with community members, making it easier for families to get to study visits, and paying families for the time they spend participating in the study. Not having enough staff and resources were listed as barriers to enrolling children and helping them stay enrolled in studies.

What do the results mean?

More studies are needed to understand the best ways to engage children and their families in rural areas in clinical trials. While many of the factors identified in this review that are barriers to or supporting of research are common across all research—such as participant reminders, building relationships with families, and adequate resources—it is critical that study teams look specifically at issues important to rural communities—such as paying for travel costs and facilitating delivery of study materials to remote sites.

Why was this study conducted?

Good clinical trials can help improve patient health outcomes by informing evidence-based medicine and public health interventions. However, children and adults who live in rural settings are underrepresented in clinical trials. This can affect the quality of health care for rural populations and contribute to rural health disparities.

You may learn more about this publication here: https://ascpt.onlinelibrary.wiley.com/doi/10.1111/cts.13220

The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

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Facilitators and Barriers to Pediatric Clinical Trial Recruitment and Retention in Rural and Community Settings: A Scoping Review of the Literature

Study Summary: Lay Summary for Participant Families