Standardizing the Clinical Definition of Opioid Withdrawal in the Neonate

J Pediatr. 2022 Apr:243:33-39.e1. doi: 10.1016/j.jpeds.2021.12.021. Epub 2021 Dec 20.


Objective: To standardize the clinical definition of opioid withdrawal in neonates to address challenges in clinical care, quality improvement, research, and public policy for this patient population.

Study design: Between October and December 2020, we conducted 2 modified-Delphi panels using ExpertLens, a virtual platform for performing iterative expert engagement panels. Twenty clinical experts specializing in care for the substance-exposed mother-neonate dyad explored the necessity of key evidence-based clinical elements in defining opioid withdrawal in the neonate leading to a diagnosis of neonatal abstinence syndrome (NAS)/neonatal opioid withdrawal syndrome (NOWS). Expert consensus was assessed using descriptive statistics, the RAND/UCLA Appropriateness Method, and thematic analysis of participants' comments.

Results: Expert panels concluded the following were required for diagnosis: in utero exposure (known by history, not necessarily by toxicology testing) to opioids with or without the presence of other psychotropic substances, and the presence of at least two of the most common clinical signs characteristic of withdrawal (excessive crying, fragmented sleep, tremors, increased muscle tone, gastrointestinal dysfunction).

Conclusions: Results indicate that both a known history of in utero opioid exposure and a distinct set of withdrawal signs are necessary to standardize a definition of neonatal withdrawal. Implementation of a standardized definition requires both patient engagement and a mother-neonate dyadic approach mindful of program and policy implications.

Keywords: neonatal abstinence syndrome; neonatal opioid withdrawal syndrome.

Publication types

  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Analgesics, Opioid / adverse effects
  • Female
  • Humans
  • Infant, Newborn
  • Mothers
  • Narcotics / therapeutic use
  • Neonatal Abstinence Syndrome* / drug therapy
  • Opioid-Related Disorders* / diagnosis
  • Opioid-Related Disorders* / drug therapy
  • Sleep Initiation and Maintenance Disorders*


  • Analgesics, Opioid
  • Narcotics