Cover: Informing the Development of a Standardized Clinical Definition of Neonatal Abstinence Syndrome

Informing the Development of a Standardized Clinical Definition of Neonatal Abstinence Syndrome

Protocol for a Modified-Delphi Expert Panel

Published in: JMIR Research Protocols (2021). doi: 10.2196/25387

Posted on Jul 23, 2021

by Dmitry Khodyakov, Shahla Jilani, Stephanie Dellva, Laura J. Faherty


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. 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 and analysis

We will conduct two three-round online modified-Delphi panels using the ExpertLensTM system and will follow recommendations for Conducting and REporting of DElphi Studies (CREDES). One panel will focus on developing key components of a clinical definition of NAS; 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. The results of these panels will be used to inform the clinical definition of NAS and will be disseminated and discussed at a national conference on NAS.


This study will inform the development of clinical definition of NAS based on input from clinical experts.


A standardized clinical definition of NAS will help to better characterize NAS incidence and design effective clinical, public health, and policy interventions to support opioid-exposed mother-infant dyads.

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