The Power of Connection:
Improving Care for Infants Exposed to Opioids

The nation’s opioid crisis has affected people and families of all ages, including babies in the first days of life. Every day in the United States, 60 infants are born with neonatal opioid withdrawal syndrome, or NOWS. Those first days and weeks of life are a critical period for both babies and mothers, and a key area of research focus for the NIH HEAL Initiative. Finding the best approaches to address the medical and social needs of these children as they grow is critical for the future health of our country.

Today we are seeing the return on this investment with major new findings that will change clinical care. HEAL researchers through the Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) research program show that using the Eat, Sleep, Console (ESC) care approach cut hospital stays by nearly 7 days for babies experiencing extreme discomfort and withdrawal symptoms. The ESC care approach also reduced by 63% the infants’ need for opioid medications to recover from withdrawal symptoms. ESC prioritizes non-opioid care as a first line of treatment – including involving mothers as therapy with skin-to-skin contact, holding, swaddling, and rocking in a low light and quiet environment.

Then and Now

For nearly 50 years, hospitals cared for infants born with NOWS using different approaches. Many babies with NOWS are given morphine and methadone to manage symptoms from opioid dependence, but other medications can also be given to treat withdrawal symptoms. When and how much to prescribe opioids varies widely. HEAL recognized that clinical research could help fill this knowledge gap toward identifying a standard of care everyone could follow.

To solve this problem, NIH-funded research first looked across the United States and found significant differences in how hospitals evaluate infants born with NOWS: hospital stays for infants ranged from 2 days to 2 weeks. The ACT NOW research team then got to work comparing the two main assessment approaches being used to guide NOWS treatment (ESC and the Finnegan Neonatal Abstinence Scoring Tool, or FNAST). FNAST is an extensive scoring system that measures signs of withdrawal in infants in various ways every 4 hours. It looks at a wide range of things, including the ability to sleep and eat, but it also documents many other symptoms such as sneezing and congestion, sweating and heart rate, dirty diapers, and others. The scoring for all these measures may be subjective and overestimate the need for opioid treatment.

The Eat, Sleep, Console care approach is an alternate strategy developed 8 years ago, and it is also widely used in hospitals. The ESC care approach is focused on function. Can a baby do what it’s supposed to do: eat, sleep, and be calmed by soothing and rocking? For the most part, if the answer to these questions is “yes,” then opioids are unlikely to be needed. ESC care encourages parents and other primary caregivers to be directly involved, emphasizing holding, swaddling, and rocking in low-stimulus environments. The care approach is also family focused, “empowering mothers in the care of their infants and letting them feel valued as mothers,” as noted by Leslie Young, M.D., of the University of Vermont who co-led this HEAL-funded clinical trial with Lori Devlin, D.O., of the University of Louisville in Kentucky.

Connecting Research and Community Experts

Aside from the health implications for babies and their families from these new research findings, there’s another important story. This discovery process was accelerated by HEAL leveraging several ongoing research efforts. By doing so, we reached more infants in more hospitals in very diverse clinical environments across America. It’s never easy to move research to practice, but it is easier when you’ve worked closely with different types of end users to identify their strengths and challenges.

ACT NOW is a partnership between the IDeA States Pediatric Clinical Trials Network (itself a part of the NIH Environmental influences on Child Health Outcomes program) and the Neonatal Research Network, funded by the NIH Eunice Kennedy Shriver National Institute of Child Health and Human Development. The Eat, Sleep, Console clinical trial was conducted across 18 states and included 1,305 infants and their primary caregivers at more than 2 dozen hospitals in urban and rural environments. This diversity enabled the research team to address the needs of communities that have been hit especially hard by the opioid crisis. The research results are also more likely to be generalizable across the country. Conducted mostly during the COVID-19 pandemic, the Eat, Sleep, Console research team faced many challenges but rose to the occasion – everyone on the team is deeply invested in improving care for this young population. The team trained about 5,000 nurses in the ESC care approach.

Hope for the Future

The national addiction and overdose crisis can feel overwhelming. Through evidence-based care and empowering people, research like the Eat, Sleep, Console study is making a difference in the lives of individuals and communities across America. This important work relies on strong partnerships with federal agencies, the private sector, research institutions, communities, collaboration, and dedication to infants and their families.

The ACT NOW research program will continue to monitor children within this clinical trial for 2 years to look for any potential effects on the well-being of infants and their families as well as monitor the infants’ development. Ongoing HEAL research is also comparing rapid with slow opioid weaning approaches for babies with NOWS as well as tracking brain imaging and other health aspects in infants with and without NOWS. These research efforts aim to better understand long-term effects of opioid exposure on a child’s future health. We imagine a future in which all infants born exposed to opioids during a mother’s pregnancy receive high-quality care – setting them up for a healthy future.

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