624 - Are Neonatal Neurobehavior Scores at Hospital Discharge among Newborns with Neonatal Opioid Withdrawal Syndrome Associated with the Duration of Pharmacologic Treatment?

Publication Number: 4610.624

Abbot R.. Laptook, Women & Infants Hospital of Rhode Island, North Kingstown, RI, United States; Adam Czynski, Connecticut Children's Medical Center, East Greenwich, RI, United States; Rouba A.. Chahine, RTI International, RTP, NC, United States; barry lester, The Warren Alpert Medical School of Brown University, east greenwich, RI, United States; Lynne Andreozzi, Women & Infants Hospital of Rhode Island, Providence, RI, United States; Clare Campbell Asher, University of Arkansas for Medical Sciences College of Medicine, Little Rock, AR, United States; Gwenevere White, University of Arkansas for Medical Sciences College of Medicine, Little Rock, AR, United States; Tara Venable, University of Arkansas for Medical Sciences College of Medicine, Little Rock, AR, United States; Kristen L. Benninger, Nationwide Children's Hospital, Columbus, OH, United States; Sofia Markee, University of New Mexico Hospital, Albuquerque, NM, United States; Tanner Wright, USF Health Morsani College of Medicine, Tampa, FL, United States; Brooke Yancey-Ward, University of Arkansas for Medical Sciences, Little Rock, AR, United States; for the Eunice Kennedy Shriver NICHD Neonatal Research Network and the, RTI International, Durham, NC, United States

Background: Little is known of the neurobehavioral state of newborns with neonatal opioid withdrawal syndrome (NOWS) after opioid treatment at the time of birth hospital discharge. The Neonatal Neurobehavioral Scales, 2nd edition (NNNS-II) is a comprehensive assessment of neurological integrity, behavioral function, and signs of stress.

Objective: Evaluate the association between the duration of medication treatment for NOWS and NNNS-II scores prior to discharge among newborns receiving pharmacological treatment.

Design/Methods: This is a secondary analysis of a blinded, randomized multicenter trial among newborns treated with postnatal opioids for NOWS (9/20-12/23) in 21 US hospitals of the Advancing Clinical Trials in NOWS Consortium. Newborns were ≥ 36 weeks gestation and receiving morphine or methadone as primary treatment for NOWS. After stabilization of NOWS signs using pharmacotherapy, newborns were randomized to 15% or 10% decrements of opioid dose to assess the duration of opioid treatment (first weaning dose to opioid cessation). Following protocol-driven weaning, newborns were observed for 48 hours off medication, during which the NNNS-II was administered by trained, blinded examiners. Associations between the duration of pharmacologic treatment and each summary score across the 8 NNNS-II domains (scaled 1-9) were assessed using linear mixed models adjusted for maternal therapy for opioid use disorder, maternal substance exposures, infant treatment medication, stabilization dose, randomization group, and gestational age at NNNS-II as fixed effects, with center included as a random effect.

Results: Of 189 newborns randomized, 122 had partial or complete NNNS-II scores (Table 1, characteristics) and 99 newborns had scores in all domains. The mean (sd) of gestational age at NNNS-II assessment was 41.6 (1.7) weeks. The NNNS-II summary scores did not differ between the 15% and 10% decrement groups (Table 2). The duration of pharmacologic therapy for newborns with any NNNS-II scores was skewed with a median and interquartile range of 8.0 (5.9, 12.3) days and a maximum value of 37.1 days. Preliminary adjusted analyses indicated no association between the duration of pharmacologic therapy and any domain of the NNNS-II. The estimated mean change in the NNNS-II score per each 7-day increment of pharmacologic therapy ranged from -0.13 (self-regulation) to 0.15 (tone and handling) and all p values were > 0.07.

Conclusion(s): There was no evidence that neurobehavior of newborns after pharmacologic treatment for NOWS differed with increasing duration of opioid therapy.

Table 1: Selected Characteristics of Mothers and Newborns with or without NNNS-II Scores
1 Categorical variables are represented as n (%) or n/N (%). Continuous variables are represented by mean (sd)
2 Greater than or equal to 3 visits AND prenatal care started prior to 3rd trimester
3 Most frequent exposures are: Nicotine, Fentanyl, methadone, buprenorphine, marijuana, amphetamine, opioid, benzodiazepine, heroin, Methamphetamine, SSRI, Cocaine, Gabapentin, and Oxycodone Fenton growth curves
4 Fenton growth curves
5 These categories are not exclusive
 


Table 2: Neonatal Neurobehavioral Scale (NNNS-II)
1 Responses are on a scale of 1-9. NNNS-II assessments were performed at a median (IQR) of 29.8 hours (24.5-46.3) after the last dose of opioid for 114 newborns (8 newborns were excluded due to withdrawal prior to completion of treatment).
2 Results are the mean (N, sd)