Clonidine for Neonatal Abstinence Syndrome Study

Summary

The study plans to compare the use of Clonidine versus Phenobarbital as an additional medication to neonatal morphine sulfate for treatment of newborn infants undergoing drug withdrawal symptoms due to mother's use of opioid drug use. The investigators hypothesis is that use of Clonidine will lead to shorter duration of treatment, hospital stay and thereby early discharge home.

Timeline

Start

2010-07

Primary completion

2012-08

Completion

2012-10

Outcome

Outcome not reported

Stopped (Enrollment): “Based on the planned interim analysis results at 50% recruitment, after IRB reviewed the results, further enrollment was stopped.”

Publications

• Results Surran B, Visintainer P, Chamberlain S, Kopcza K, Shah B, Singh R. Efficacy of clonidine versus phenobarbital in reducing neonatal morphine sulfate therapy days for neonatal abstinence syndrome. A prospective randomized clinical trial. J Perinatol. 2013 Dec;33(12):954-9. doi: 10.1038/jp.2013.95. Epub 2013 Aug 15.

Drugs

Indications