Best Practices for Conducting Clinical Trials with Indigenous Children in the United States

Author(s): Jennifer Shaw, Erin Semmens, May Okihiro, Johnnye Lewis, Matthew Hirschfeld, Timothy VanWagoner, Lancer Stephens, David Easa, Judith Ross, Niki Graham, Sara Watson, Edgardo Szyld, Denise Dillard, Lee Pyles, Paul Darden, John Carlson, Paul Smith, Russell McCulloh, Jessica Snowden, Sarah Adeky, Rosalyn Singleton

What was done?

The authors describe key ethical issues around conducting trials with Indigenous children. They review four case studies and provide guidance for conducting clinical trials involving Indigenous children.

What was found?

Based on their experience and a review of existing literature, the authors make three main recommendations for researchers conducting clinical trials involving Indigenous children:

Engage with Indigenous communities early and over the long-term to build trust and shared goals
Build capacity among Indigenous communities for leading and partnering on research studies
Support Indigenous community ownership of data and oversight of research conducted with Indigenous children

What do the results mean?

Clinical trials are needed to build evidence for child health interventions. Indigenous children must be included in clinical trials to reduce health disparities and improve health outcomes in these populations. These studies should be done in partnership with communities using established practices of community-engaged research.

Why was this study conducted?

The United States (US) population includes nearly 7 million Indigenous people, including:

5 million American Indian and Alaska Native (AI/AN) people, and
5 million Native Hawaiian and other Pacific Island people.

Indigenous people in the US have lower life expectancies and higher disease burdens than other groups. Indigenous children have high rates of health conditions, such as asthma, obesity, and respiratory infections, compared to the general population. Few pediatric clinical trials have included Indigenous children. However, many of these children live in rural communities where interventions are often most needed. Children can respond to medicines and other health interventions differently based on their backgrounds. This paper highlights the reasons why Indigenous children may be excluded from trials and offers suggestions for improvement.

Appreciation:

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 can read the full publication here: https://ajph.aphapublications.org/doi/10.2105/AJPH.2021.306372

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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Best Practices for Conducting Clinical Trials with Indigenous Children in the United States

Phenobarbital and Clonidine as Secondary Medications for Neonatal Opioid Withdrawal Syndrome

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Phenobarbital and Clonidine as Secondary Medications for Neonatal Opioid Withdrawal Syndrome

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

What was done?

We reviewed medical records from 30 U.S. hospitals. There were 180 babies with NOWS treated with morphine (M) and a secondary drug [phenobarbital (P) or clonidine (C)]. We compared the two groups (M + P and M + C) and calculated the number of days spent in the hospital and the number of days they received morphine.

What was found?

Babies in the M + P group had fewer days of morphine treatment compared to babies in the M + C group. They also spent fewer days in the hospital than the M + C group. However, babies in the M + P group were more likely to continue taking phenobarbital at home.

What do the results mean?

In this study, babies treated with M + P had shorter hospital stays, and in some cases, fewer days of morphine treatment. But, some studies show that long-term use of phenobarbital could cause problems with the development of the nervous system. More research is needed on the benefits and risks of using this drug to treat NOWS symptoms.

Why was this study conducted?

Babies exposed to opioids (e.g., morphine, methadone, etc.) in the womb may have drug withdrawal symptoms called neonatal opioid withdrawal syndrome (NOWS) after birth. Some are given medicine for their symptoms. If the medicine doesn’t work, doctors may add other (secondary) medicine to the treatment. This study looked at two secondary drugs used most often to see if one was better than the other in NOWS treatment.

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. The authors thank 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 for supporting this research.

Access the full journal article, titled "Phenobarbital and Clonidine as Secondary Medications for Neonatal Opioid Withdrawal Syndrome," published in Pediatrics.

Published March, 2021

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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Phenobarbital and Clonidine as Secondary Medications for Neonatal Opioid Withdrawal Syndrome

Resources

Centers for Disease Control and Prevention (CDC)

About Opioid Use During Pregnancy

Related Research Summaries

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

How does prenatal opioid exposure affect child outcomes?

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

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

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

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

What was done?

The medical records of babies born between July 1, 2016 and June 30, 2017 and their mothers were reviewed at 30 U.S. hospitals. From these records, 1377 babies were selected for the study.

For the babies, we looked at how many were given medicines for their NOWS symptoms and what they ate. We also looked at how long they were in the hospital, and who they went home with. For the mothers, we looked at what types of care they had during their pregnancy.

What was found?

The hospitals in this study varied in how they took care of pregnant women with opioid use and their babies.

In the babies:

6% to 100% received medicine for NOWS symptoms,
22% to 83% were fed breast milk,
length of hospital stay was 2 to 28 days, and
33% to 91% went home with their parents.

In the mothers:

6% to 100% were given medicine for their opioid use disorder,
31% to 100% received adequate medical care during their pregnancy, and
2% to 75% received prenatal counseling.

What do the results mean?

This study suggests that the care for pregnant women who use opioids and their babies differs widely in the U.S. This means that some mothers and babies may not be getting the best care.

More research into the care we provide will help doctors find a standardized way to care for babies with NOWS. Standardized care will help all babies with NOWS get the best care possible.

Why was this study conducted?

Babies exposed to opioids in the womb may show signs of withdrawal after birth. This is called neonatal opioid withdrawal syndrome (NOWS). Babies with NOWS may tremble, have increased crying, or be more difficult to calm. They also may not sleep or eat well.

In the U.S., there is not a standard way to care for babies with NOWS after they are born. That means U.S. doctors may be treating babies with NOWS in different ways. This study looked at the variation in the care provided to babies with NOWS in the U.S.

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. The authors thank 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 for supporting this research.

Access the full journal article, titled "Site-Level Variation in the Characteristics and Care of Infants With Neonatal Opioid Withdrawal," published in Pediatrics.

Published January 2021

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

Download this summary

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

Resources

Centers for Disease Control and Prevention (CDC)

About Opioid Use During Pregnancy

Related Research Summaries

Phenobarbital and Clonidine as Secondary Medications for Neonatal Opioid Withdrawal Syndrome

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

How does prenatal opioid exposure affect child outcomes?

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

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

<< Back to Research Summaries

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

What was done?

In the fall of 2017, 54 sites within two research networks were surveyed. The sites were asked about the protocols and practices they used to treat NOWS infants. They were also asked how NOWS infants were diagnosed, what drugs they were given, what non-drug methods were used, and what areas of the hospital cared for NOWS infants.

What was found?

Sites could be divided into those that were NICUs (neonatal intensive care units) and those that were not ICUs (non-ICUs). NICUs were more likely to have protocols for screening mothers and diagnosing NOWs. They were also more likely to have protocols for how to give drugs for NOWS symptoms and encouraging breastfeeding. NICUs were more likely to use non-drug methods to treat NOWS infants.

Non-drug methods included swaddling, cuddling, massage, and low-stimulation environments. Morphine was the first drug of choice for NOWS symptoms at a majority of sites, regardless of their type.

What do the results mean?

Non-ICU sites need targeted training and standardized care plans for NOWS infants. However, it is not clear which practices are the most beneficial. Some variations in care may be best for some NOWS infants. The long-term effects of drug therapy and non-drug methods in these infants are unknown. The variations seen in this study show the need for multisite clinical trials in infants with NOWS. These studies will help define the best policies and practices to use with NOWS infants.

Why was this study conducted?

Neonatal opioid withdrawal syndrome (NOWS) often occurs when the mothers of unborn babies use opioids. The number of babies with NOWS has dramatically increased in the last 10 years due to the opioid crisis in the US. Doctors and hospitals have developed standard protocols on how best to care for these babies. The goal of this study was to collect information on how hospitals care for NOWS infants and to use this information for future clinical studies on the best methods to care for them.

Appreciation:

The authors especially thank the sites of the Institutional Development Award States Pediatric Clinical Trials Network and the Neonatal Research Network for contributing participating in the survey. The authors would also like to thank 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 for supporting this research.

You may learn more about this publication here: https://www.ncbi.nlm.nih.gov/pubmed/31324654

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

Download this summary

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

Training as an Intervention to Decrease Medical Record Abstraction Errors Multicenter Studies

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Training as an Intervention to Decrease Medical Record Abstraction Errors Multicenter Studies

Author(s): Meredith Zozus, Leslie Young, Alan Simon, et al

What was done?

MRA training was delivered at the beginning of the study. The training consisted of a teaching session using an example case abstraction, followed by each trainee independently abstracting two test cases. Sixty-nine abstractors from 30 sites received the MRA training. The goal for each abstractor was to achieve an error rate no greater than 4.93%.

What was found?

Only 23% of the abstractors met their error rate goal during the training.

What do the results mean?

Study-specific MRA training can improve the quality of study data. This project had several problems. Creating the training test cases took a lot of time and effort. When the training test cases were created, they contained errors that were not discovered before training began. These errors were distracting and confusing to the abstractors. Lastly, there are many different EMR systems and it is impossible to train abstractors on all of them.

Why was this study conducted?

Searching medical records to find data for another use is called medical record abstraction (MRA). The process is prone to errors, and many people question the quality of the data. This project trained abstractors for a study that used MRA as the main source of data.

Appreciation:

The authors would like to thank the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health for their support of this research.

You may learn more about this publication here: https://www.ncbi.nlm.nih.gov/pubmed/30741251

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

Download this summary

Training as an Intervention to Decrease Medical Record Abstraction Errors Multicenter Studies