ORIGINAL RESEARCH article

Front. Pediatr.

Sec. Neonatology

Volume 13 - 2025 | doi: 10.3389/fped.2025.1527276

This article is part of the Research TopicEnhancing Drug Safety for Pregnant and Lactating Women: Addressing Perinatal Pharmacotherapy ChallengesView all 6 articles

Clinical and Demographic Predictors of the Need for Pharmacotherapy in Neonatal Abstinence Syndrome

Provisionally accepted
Shawana  BibiShawana Bibi1,2,3*Rachana  SinghRachana Singh4Janis  L BreezeJanis L Breeze2Jason  NelsonJason Nelson2Walter  Karl KraftWalter Karl Kraft5Jonathan  M DavisJonathan M Davis2,4
  • 1Cleveland Clinic, Cleveland, United States
  • 2Tufts Clinical and Translational Science Institute, Tufts University, Boston, Massachusetts, United States
  • 3Case Western Reserve University, Cleveland, Ohio, United States
  • 4School of Medicine, Tufts University, Boston, Massachusetts, United States
  • 5Thomas Jefferson University, Philadelphia, Pennsylvania, United States

The final, formatted version of the article will be published soon.

Objective: Development and validation of a clinical prediction model for receipt of pharmacotherapy for Neonatal Abstinence Syndrome (NAS). Study Design: Data from three cohorts included in-utero opioid exposed neonates ≥37 weeks gestation. Primary outcome was the receipt of pharmacotherapy utilizing a modified Finnegan Neonatal Abstinence Scoring System (FNASS). A stepwise multivariable logistic regression model was built and internally validated. Results: Of 698 infants included, 430 received pharmacotherapy. The final model included seven predictors of receipt of pharmacotherapy: gestational age, exposure to maternal breast milk, type of maternal opioid medication, and exposure to heroin, cocaine, benzodiazepines, and/or antipsychotic medications. The model had an AUROC of 0.68 (95 % CI: 0.64-0.72; optimism corrected 0.65).Our prediction model was parsimonious and identified seven predictors associated with the need for PT. Larger cohort studies are needed to more definitively establish risk of significant NAS requiring pharmacotherapy.

Keywords: neonatal, Abstinence syndrome, predictors, clinical, Pharmacotherapy

Received: 13 Nov 2024; Accepted: 14 Jul 2025.

Copyright: © 2025 Bibi, Singh, Breeze, Nelson, Kraft and Davis. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence: Shawana Bibi, Cleveland Clinic, Cleveland, United States

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