HHS Announces a Standard Clinical Definition for Opioid Withdrawal in Infants

Jennifer E. Engen

Co-led by Hendrée Jones, PhD, at the UNC School of Medicine, this work is major step towards improving standards of care for infants prenatally exposed to opioids, part of the HHS Overdose Prevention Strategy.


The U.S. Department of Health and Human Services (HHS) together with leading clinicians, researchers, and policy experts led the development of a standard clinical definition for opioid withdrawal in infants to help improve care. It is accompanied with a set of foundational principles that outlines bioethical uses for the definition, distinctly centering around identifying clinical and supportive care needs of mothers and their infants, using an evidence-based, compassionate, and equitable approach.

The new standard clinical definition of opioid withdrawal in neonates is published in The Journal of Pediatrics, and the full DHHS press release was published online today.

The lead co-authors of the Journal of Pediatrics publication are Shahla Jilani, MD, of the DHHS, and Hendrée Jones, PhD, executive director of the UNC Horizons program and professor of obstetrics and gynecology at the UNC School of Medicine.

Across the U.S., the number of mothers with opioid-related diagnoses documented at delivery increased approximately 130% from 2010 to 2017, according to a 2021 report. Yet infants born with opioid exposure and withdrawal often lack consistent diagnosis and care.

The new standard clinical definition for diagnosis includes prenatal exposure and specific evidence-based clinical signs such as excessive crying, fragmented sleep, tremors, increased muscle tone, and gastrointestinal disfunction. It can be applied in the context of neonatal abstinence syndrome or neonatal opioid withdrawal syndrome, terminologies typically used to describe withdrawal due to prenatal substance exposure in infants. The definition also includes bioethical principles emphasizing that it is not meant to prove or imply harm, nor should it be used to assess child social welfare risk or status.

This is a major step forward towards improving standards of care for infants prenatally exposed to opioids, part of the HHS Overdose Prevention Strategy, through:

Diagnosis: Providing a consistent way to diagnose infants, which will lead to better infant care;

Data: Informing medical coding practices to improve health care data collection for infants affected by opioid exposure;

Programs: Informing surveillance practices, helping to understand the short- and long-term needs of affected communities, which will lead to better programs, and better resources to help both mother and infant;

Research: Informing and optimizing research study design by having a consistent way to define opioid withdrawal in infants, which will lead to better research data to develop and guide better treatments;

Health Equity: Accompanying bioethical principles that inform clinical use of the definition aim to reduce stigma and protect mothers and infants so they get the care they need without fear of reprisal.

UNC School of Medicine contact: Mark Derewicz

HHS Announces a Standard Clinical Definition for Opioid Withdrawal in Infants

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