Henrietta S Bada1, Thitinart Sithisarn2, Julia Gibson3, Karen Garlitz3, Rhonda Caldwell2, Gilson Capilouto4, Yinglei Li5, Markos Leggas6, Patrick Breheny7. 1. Departments of Pediatrics, College of Medicine, hbada2@uky.edu. 2. Departments of Pediatrics, College of Medicine. 3. Department of Pharmacy, Kentucky Children's Hospital, Lexington, Kentucky; and. 4. Rehabilitation Sciences, College of Health Sciences. 5. Statistics, College of Arts and Sciences and. 6. Pharmaceutical Sciences, College of Pharmacy, University of Kentucky, Lexington, Kentucky; 7. Department of Biostatistics, College of Public Health, University of Iowa, Iowa City, Iowa.
Abstract
OBJECTIVE: The study goal was to determine whether clonidine treatment of neonatal abstinence syndrome (NAS) would result in a better neurobehavioral performance compared with morphine. METHODS: This pilot study prospectively enrolled infants ≥ 35 weeks' gestational age admitted for treatment of NAS. After informed consent was obtained, infants were randomized to receive morphine (0.4 mg/kg per day) or clonidine (5 μg/kg per day) divided into 8 doses. A 25% dose escalation every 24 hours was possible per protocol (maximum of 1 mg/kg per day for morphine and 12 μg/kg per day for clonidine). After control of symptoms, the dose was tapered by 10% every other day. Clinical staff monitored infants by using Finnegan scoring. Masked research staff administered the NICU Network Neurobehavioral Scale (NNNS) at 1 week and at 2 to 4 weeks after initiation of treatment and the Bayley Scales III, and Preschool Language Scale IV, at 1-year adjusted age. Analyses included descriptive statistics, repeated measures analysis of variance, and Wilcoxon tests. RESULTS: Infants treated with morphine (n = 15) versus clonidine (n = 16) did not differ in birth weight or age at treatment. Treatment duration was significantly longer for morphine (median 39 days) than for clonidine (median 28 days; P = .02). NNNS summary scores improved significantly with clonidine but not with morphine. On subsequent assessment, those receiving clonidine had lower height of arousal and excitability (P < .05). One-year motor, cognitive, and language scores did not differ between groups. CONCLUSIONS:Clonidine may be a favorable alternative to morphine as a single-drug therapy for NAS. A multicenter randomized trial is warranted.
RCT Entities:
OBJECTIVE: The study goal was to determine whether clonidine treatment of neonatal abstinence syndrome (NAS) would result in a better neurobehavioral performance compared with morphine. METHODS: This pilot study prospectively enrolled infants ≥ 35 weeks' gestational age admitted for treatment of NAS. After informed consent was obtained, infants were randomized to receive morphine (0.4 mg/kg per day) or clonidine (5 μg/kg per day) divided into 8 doses. A 25% dose escalation every 24 hours was possible per protocol (maximum of 1 mg/kg per day for morphine and 12 μg/kg per day for clonidine). After control of symptoms, the dose was tapered by 10% every other day. Clinical staff monitored infants by using Finnegan scoring. Masked research staff administered the NICU Network Neurobehavioral Scale (NNNS) at 1 week and at 2 to 4 weeks after initiation of treatment and the Bayley Scales III, and Preschool Language Scale IV, at 1-year adjusted age. Analyses included descriptive statistics, repeated measures analysis of variance, and Wilcoxon tests. RESULTS:Infants treated with morphine (n = 15) versus clonidine (n = 16) did not differ in birth weight or age at treatment. Treatment duration was significantly longer for morphine (median 39 days) than for clonidine (median 28 days; P = .02). NNNS summary scores improved significantly with clonidine but not with morphine. On subsequent assessment, those receiving clonidine had lower height of arousal and excitability (P < .05). One-year motor, cognitive, and language scores did not differ between groups. CONCLUSIONS:Clonidine may be a favorable alternative to morphine as a single-drug therapy for NAS. A multicenter randomized trial is warranted.
Authors: Tess Flannery; Jonathan M Davis; Adam J Czynski; Lynne M Dansereau; Erica L Oliveira; Samantha A Camardo; Barry M Lester Journal: J Pediatr Date: 2020-08-14 Impact factor: 4.406
Authors: Stephanie L Merhar; Songthip Ounpraseuth; Lori A Devlin; Brenda B Poindexter; Leslie W Young; Sean D Berkey; Moira Crowley; Adam J Czynski; Autumn S Kiefer; Bonny L Whalen; Abhik Das; Janell F Fuller; Rosemary D Higgins; Vaishali Thombre; Barry M Lester; P Brian Smith; Sarah Newman; Pablo J Sánchez; M Cody Smith; Alan E Simon Journal: Pediatrics Date: 2021-03 Impact factor: 7.124