To determine if treatment with a 5-HT3 antagonist (ondansetron) reduces need for opioid therapy in infants at risk for neonatal opioid withdrawal syndrome (NOWS).
A multicenter, randomized, placebo controlled, double blind clinical trial of ninety (90) infants. The intervention arms were intravenous ondansetron or placebo during labor followed by a daily dose of ondansetron or placebo in infants for five days.
Twenty-two (49%) ondansetron-treated and 26 (63%) placebo-treated infants required pharmacologic treatment (p > 0.05). The Finnegan score was lower in the ondansetron-treated group (4.6 vs. 5.6, p = 0.02). A non-significant trend was noted for the duration of hospitalization. There was no difference in need for phenobarbital or clonidine therapy, or total dose of morphine in the first 15 days of NOWS treatment.
Ondansetron treatment reduced the severity of NOWS symptoms; and there was an indication that it could reduce the length of stay.
Clinical Trial Registration
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The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
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We acknowledge the work of the following site principal investigators who assisted in the conduct of the study. Lori A. Devlin, MD (Univ. of Louisville), Ramasubbareddy Dhanireddy, MD (University of Tennessee Health Science Center), Ronald S. Cohen, MD (Lucile Packard Children’s Hospital), Camille M. Fung, MD (University of Utah), Juan E. Vargas, MD (University of California, San Francisco General Hospital). This trial was supported by National Institute of Drugs of Abuse (NIDA) R01 HD070795-06A1. Gary Petlz and Manhong Wu were also supported by a NIH/NIDA award 5U01DA04439902. The other authors received no additional funding. The NIH had no role in the design and conduct of the study.
Participating sites (number of subjects enrolled)
Thomas Jefferson University (42)
Johns Hopkins Bayview Medical Center (31)
Santa Clara Valley Medical Center (13)
University of Louisville (4)
University of Tennessee Health Science Center (3)
Lucile Packard Children’s Hospital (2)
University of Utah (2)
University of California, San Francisco General Hospital (1)
The authors declare no competing interests.
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Peltz, G., Jansson, L.M., Adeniyi-Jones, S. et al. Ondansetron to reduce neonatal opioid withdrawal severity a randomized clinical trial. J Perinatol 43, 271–276 (2023). https://doi.org/10.1038/s41372-022-01487-2