Trial reportJournal of perinatology : official journal of the California Perinatal Association2013
Efficacy of clonidine versus phenobarbital in reducing neonatal morphine sulfate therapy days for neonatal abstinence syndrome. A prospective randomized clinical trial.
Trial report in Journal of perinatology : official journal of the California Perinatal Association, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01175668 (Comparison of Clonidine Versus Phenobarbital as an Adjunct Therapy for Neonatal Abstinence Syndrome), which is not on this map. Cited by 35 papers, 6 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Comparison of Clonidine Versus Phenobarbital as an Adjunct Therapy for Neonatal Abstinence Syndrome
Who cites it
35 citing papers in PubMed, 6 syntheses or guidelines pooled it, 82 citations in OpenAlex.
- Opioid treatment for opioid withdrawal in newborn infants.The Cochrane database of systematic reviews · 2021Pooled it
- Sedatives for opioid withdrawal in newborn infants.The Cochrane database of systematic reviews · 2021Pooled it
- Outcome reporting in neonates experiencing withdrawal following opioid exposure in pregnancy: a systematic review.Trials · 2020Pooled it
- Therapeutic approaches for neonatal abstinence syndrome: a systematic review of randomized clinical trials.Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences · 2019Pooled it
- Pharmacological Treatments for Neonatal Abstinence Syndrome: A Systematic Review and Network Meta-analysis.JAMA pediatrics · 2019Pooled it
- Review of the assessment and management of neonatal abstinence syndrome.Addiction science & clinical practice · 2014Pooled it
- Pharmacokinetic Modeling and Model-Based Hypothesis Generation for Dose Optimization of Clonidine in Neonates With Neonatal Opioid Withdrawal Syndrome.Clinical pharmacology and therapeutics · 2025Trial
- Comparison of the effect of phenobarbital & levetiracetam in the treatment of neonatal abstinence syndrome (NAS) as adjuvant treatment in neonates admitted to the neonatal intensive care unit: a randomized clinical trial.BMC pregnancy and childbirth · 2024Trial
- Lactose-free infant formula does not change outcomes of neonatal abstinence syndrome (NAS): a randomized clinical trial.Journal of perinatology : official journal of the California Perinatal Association · 2021Trial
- Comparison of Safety and Efficacy of Methadone vs Morphine for Treatment of Neonatal Abstinence Syndrome: A Randomized Clinical Trial.JAMA pediatrics · 2018Trial
- Methadone versus morphine for treatment of neonatal abstinence syndrome: a prospective randomized clinical trial.Journal of perinatology : official journal of the California Perinatal Association · 2015Trial
- Neonatal Abstinence Signs during Treatment: Trajectory, Resurgence and Heterogeneity.Children (Basel, Switzerland) · 2024Article
- Severe irritability in a critically ill preterm infant: a case of delirium at the neonatal intensive care unit.Dementia & neuropsychologia · 2023Article
- Neonatal Abstinence Syndrome: A Review of Treatment in the Neonatal Intensive Care Unit.The Canadian journal of hospital pharmacy · 2023Article
- Project Console: a quality improvement initiative for neonatal abstinence syndrome in a children's hospital level IV neonatal intensive care unit.BMJ open quality · 2021Article
- Phenobarbital and Clonidine as Secondary Medications for Neonatal Opioid Withdrawal Syndrome.Pediatrics · 2021Article
- Neonatal Abstinence Syndrome Practices in the United States.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2021Article
- A Retrospective Review Following the Addition of Clonidine to a Neonatal Abstinence Syndrome Treatment Algorithm.Frontiers in pediatrics · 2021Article
- Use of Phenobarbital to Treat Neonatal Abstinence Syndrome From Exposure to Single vs. Multiple Substances.Frontiers in pediatrics · 2021Article
- Clonidine versus phenobarbital as adjunctive therapy for neonatal abstinence syndrome.Journal of perinatology : official journal of the California Perinatal Association · 2020Article
Corrections and comments
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Authors and funding
6 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo compare the efficacy of clonidine versus phenobarbital in reducing morphine sulfate treatment days for neonatal abstinence syndrome (NAS). STUDY
designProspective, non-blinded, block randomized trial at a single level III NICU (Neonatal Intensive Care Unit). Eligible infants were treated with a combination of medications as per protocol. Primary outcome was treatment days with morphine sulfate. Secondary outcomes were the mean total morphine sulfate dose, outpatient phenobarbital days, adverse events and treatment failures.
resultsA total of 82 infants were eligible, of which 68 were randomized with 34 infants in each study group. Adjusting for covariates phenobarbital as compared with clonidine had shorter morphine sulfate treatment days (-4.6, 95% confidence interval (CI): -0.3, -8.9; P=0.037) with no difference in average morphine sulfate total dose (1.1 mg kg(-1), 95% CI: -0.1, 2.4; P=0.069). Post-discharge phenobarbital was continued for an average of 3.8 months (range 1 to 8 months). No other significant differences were noted.
conclusionPhenobarbital as adjunct had clinically nonsignificant shorter inpatient but significant overall longer therapy time as compared with clonidine.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.