Informing the Development of a Standardized Clinical Definition of Neonatal Abstinence Syndrome: Protocol for a Modified-Delphi Expert Panel

Background: Neonatal abstinence syndrome (NAS) is a postnatal withdrawal syndrome that most commonly results from prenatal opioid exposure. Every 15 minutes, an infant is born in the United States with signs of NAS. The field lacks a standardized clinical definition of NAS, complicating discussions on programmatic and policy development to support opioid-exposed mothers and infants. Objective: The goal of this paper is to describe a protocol for a systematic expert panel process to inform the development of a clinical definition of NAS. Methods: We will conduct two three-round online modified-Delphi panels using the ExpertLens system and will follow the recommendations for Conducting and REporting of DElphi Studies (CREDES). One panel will focus on developing key components of a clinical definition of NAS, and the second panel will focus on neonatal opioid withdrawal syndrome (NOWS), which is a term that has come into use to differentiate opioid-exposed infants from infants exposed to other substances in utero. However, there is lack of agreement on the precise clinical definition of NOWS and how it is distinct from or overlaps with NAS. Each panel will complete two rating rounds and a discussion round using a similar protocol. We will analyze all rating data descriptively and determine the presence of agreement within and between the two panels. We will also perform thematic analysis of the qualitative comments to contextualize the panel findings. Results: The panels were convened between October 29 and December 17, 2020. Their results were disseminated and discussed at a national conference on NAS that took place on March 17-18, 2021. Conclusions: A standardized clinical definition of NAS will help to better characterize NAS incidence and to design effective clinical, public health, and policy interventions to support opioid-exposed mother-infant dyads.