Clonidine Could Be Effective Treatment for Neonatal Opioid Withdrawal Syndrome
Clonidine may be an effective non-opioid medication to be used to treat neonatal opioid withdrawal syndrome (NOWS), according to recent results from an intention-to-treat randomized clinical trial published in Pediatrics.
“Length of pharmacologic treatment and final neurobehavioral performance were not significantly different between the clonidine- and morphine-treated groups,” noted lead author Henrietta S. Bada, MD, Department of Pediatrics, University of Kentucky College of Medicine, and co-authors. “Clonidine appears to be an effective non-opioid medication to treat NOWS.”
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Enrollment criteria for participants included prenatal opioid exposure, age ≤7 days, gestational age ≥35 weeks, no other medical conditions, and need for pharmacotherapy. Primary outcomes were length of treatment and neurobehavioral performance. All infants received non-pharmacological intervention (swaddling, low noise, lighting environment, rooming in, infant massage, etc). Throughout the hospital stay, infants were monitored using the Finnegan Neonatal Abstinence Scoring System, which guided the initiation and monitoring of treatment, allowing for comparison with other treatment studies.
Though 1107 patients were screened for enrollment, a total of 155 infants were included in the final study. Of which, 120 required treatment and were randomized to receive oral clonidine (n = 60) at 1 µg/kg/dose or morphine (n = 60), 0.06 mg/kg/dose, every 3 hours. Infants with no improvement had their doses increased by 25% of the initial dose every 12 to 24 hours. Those without improvement by the fourth dose increase received adjunct therapy. Treatment length did not differ between morphine and clonidine, with median (95% confidence interval [CI]) days, respectively, of 15 (13–17) and 17 (15–19), P = .48. More clonidine-treated infants (45%) needed adjunct therapy versus 10% in the morphine group, adjusted odds ratio (95% CI) = 8.85 (2.87–27.31). After treatment completion, the NICU Network Neurobehavioral Scales summary scores did not differ between clonidine-treated and morphine-treated infants.
“Future studies are needed to investigate the optimal dose and frequency of clonidine administration for improved efficacy and the decreased need for adjunctive therapy in NOWS,” authors concluded.
This study was limited by its inability to demonstrate equivalence or non-inferiority, partly due to the smaller sample size influenced by the COVID-19 pandemic. The single-site design restricts the generalizability of findings, though it provides valuable insights into infants from rural areas. Additionally, the high prevalence of maternal medication for opioid use disorder (MOUD) and polydrug use highlights the need for larger studies to better understand their impact on NOWS treatment outcomes.
