Standardizing the Clinical Definition of Opioid Withdrawal in the Neonate

Objective

To address challenges in clinical care, quality improvement, research, and public policy for prenatally opioid-exposed neonates by standardizing the clinical definition of opioid withdrawal.

Study Design

Between October and December 2020, we conducted two 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) 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/continuous 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/harmonize 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.