Symptom-Based Dosing for Neonatal Opioid Withdrawal: The OPTimize NOW Randomized Clinical Trial.
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Devlin Lori A, Babineau Denise C, Merhar Stephanie L, DeMauro Sara B, Kraft Walter K, Lorch Scott A, Das Abhik, McDonald Scott A, Rhodes Evan, Schmidt Augusto F, Trochinski Lillian, Crawford Margaret, Sithisarn Thitinart, Leeman Lawrence, Kovatis Kelley Zagol, Ambalavanan Namasivayam, Smith Ryan W, Telang Sucheta, Tioseco Jennifer A, McAllister Jennifer M, Wexelblatt Scott L, Muniyappa Bhanu, Williams Patricia K, Adeniyi-Jones Susan C, Hill Crystal D, Wright Tanner, Sokol Gregory M, Johnson Lynette, Hall Richard W, Duncan Scott D, Puopolo Karen, Dummula Krishna, Anderson-Berry Ann, Davis Jonathan M, Poindexter Brenda, Young Leslie W, HEAL Evaluation of Limited Pharmacotherapies for Neonatal Opioid Withdrawal Syndrome (HELP for NOWS) Consortium
Аннотация
OBJECTIVE: To compare time from birth to medical readiness for discharge for infants with moderate to severe withdrawal treated with either a symptom-based dosing or scheduled opioid taper approach.
DESIGN, SETTING, AND PARTICIPANTS: In this cluster, crossover randomized clinical trial with run-in period, 23 US hospitals cared for infants using the Eat, Sleep, Console approach (ESC) or Finnegan-based care (a comprehensive scoring system to quantify severity of symptoms; 15 ESC and 8 Finnegan hospitals) and their preferred primary opioid. Opioid dosing was guided by study-approved, site-specific algorithms. Infants with NOWS with a gestational age at birth of at least 36 weeks and at risk for pharmacologic treatment were enrolled between March 25, 2024, and April 9, 2025, with the last 3-month assessment on July 15, 2025. Sample size analyses were conducted between August 1, 2024, and September 23, 2024.
INTERVENTION: Sites were randomized to 1 of 2 sequences: (1) symptom-based dosing followed by scheduled opioid taper or (2) scheduled opioid taper followed by symptom-based dosing.
MAIN OUTCOME AND MEASURE: Time from birth to medical readiness for discharge.
RESULTS: Of the 626 enrolled infants (mean [SD] gestational age, 38 [1] weeks; 49% male), 383 were cared for with ESC (primary outcome cohort). The mean time to medical readiness for discharge was significantly shorter in the symptom-based dosing group compared with the scheduled opioid taper group (9.18 vs 11.61 days; adjusted mean ratio [aMR], 0.79 [95% CI, 0.65-0.96]). There was no difference in the risk for initiation of pharmacologic treatment (0.4 vs 0.41; adjusted risk ratio, 0.99 [95% CI, 0.77-1.27]) or length of stay (10.91 vs 12.09 days; aMR, 0.9 [95% CI, 0.72-1.13]) between groups. For infants in the symptom-based group, 35% (95% CI, 25%-45%) required scheduled opioid dosing due to withdrawal severity that was not controlled with intermittent dosing. In the Finnegan cohort (n = 243; planned secondary outcome), there were no significant differences in time to medical readiness for discharge (15.99 vs 17.56 days; aMR, 0.91 [95% CI, 0.72-1.15]) or length of stay (17.38 vs 19.39 days; aMR, 0.9 [95% CI, 0.69-1.16]). The inpatient composite safety outcome occurred rarely (in the ESC cohort, 3 of 188 in the symptom-based dosing vs 2 of 195 in the scheduled opioid taper groups).
CONCLUSIONS AND RELEVANCE: Symptom-based dosing decreased time to medical readiness for discharge compared with a scheduled opioid taper approach among infants cared for with ESC.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05980260.