531 - Developmental Outcomes at 6 and 12 Months in Infants Diagnosed with Neonatal Opioid Withdrawal Syndrome

Publication Number: 531.4547

Katie Ramdial, Cooper Medical School of Rowan University, Voorhees, NJ, United States; Owen Henry, Rady Children’s Hospital, San Diego, San Diego, CA, United States; Jack Donlon, Cooper Medical School of Rowan University, Philadelphia, PA, United States; Joseph S. Sichel, Cooper Medical School of Rowan Universit, Philadelphia, PA, United States; Pranav Patel, Cooper Medical School of Rowan University, Deptford, NJ, United States; Vishwanath Bhat, Cooper Medical School of Rowan University, Camden, NJ, United States; Vineet Bhandari, The Children's Regional Hospital at Cooper, Camden, NJ, United States; Alla Kushnir, The Children's Regional Hospital at Cooper, Camden, NJ, United States

Background: Infants treated for NOWS require close monitoring, partially due to the potential for long-term effects of prenatal and postnatal opioid exposure on brain development. Current primary therapy of NOWS is morphine sulfate (MS), an opioid. However, clonidine, a non-opioid, is another possible treatment for NOWS.

Objective: To investigate if there is a difference in developmental outcomes at 6 and 12 months in infants diagnosed with NOWS who were treated with MS versus clonidine as the primary therapy.

Design/Methods: Follow-up study of a double blinded, randomized clinical trial evaluating neonates with NOWS, between 2/2018 and 10/2024. Subjects were randomized to treatment with either MS or clonidine as primary therapy. Majority of the subjects consented for the study did not require pharmacological management (No-Tx group) and were treated with supportive therapies. Subjects' guardians completed the 6 and 12 months Ages and Stages Questionnaires (ASQ-3) over the phone. Differences in ASQ results in those treated with MS versus clonidine and those in the treated versus non-treated groups were compared using chi-square analysis.

Results: Of the 149 consented neonates, 69 (46%) received pharmacological treatment (Tx group) and of the 69 treated patients, 34 (49%) received MS and 35 (51%) clonidine. There was no significant difference in gestational age (38.1 versus 38.5 weeks), birth weight (2904 versus 3067 grams), gender (males 55% versus 52%), or race in the Tx and No-Tx groups, or between MS and clonidine group. There was no difference in developmental outcomes between the Tx and No-Tx groups at 6 or 12 months (p = 0.835, p = 0.64, respectively). There was, also, no difference in development between subjects treated with MS vs clonidine therapy at 6 months or 12 months. However, twice as many patients who were treated with MS had an abnormal ASQ at 12 months, compared to the clonidine group (66% versus 33%, p = 0.4).

Conclusion(s): There were no differences in developmental outcomes between children treated versus not treated for NOWS, and those treated with MS versus clonidine. However, those treated with morphine may have a higher chance of abnormal development at 12 months compared to those treated with clonidine, which needs to be further evaluated with larger studies.