Clinical Trial: NAS Treatment - Opiate Versus Non-Opiate

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Pharmacological Treatment of Neonatal Abstinence Syndrome: Opiate Versus Non-Opiate

Brief Summary: The purpose of this study is to compare two different medicines to treat babies with opiate withdrawal. The treatment medicines are morphine, which is an opiate, and clonidine, a non-opiate. Morphine is a narcotic medicine, with is included in most pain killers. Clonidine is another drug, but is different from morphine. It is also used for babies, and even adults for withdrawal symptoms. Both drugs are effective, but the purpose of this study is to see if one may be better than the other.

Detailed Summary: Withdrawal from drugs, called Neonatal abstinence syndrome (NAS), is a group of symptoms that occurs to babies whose mother took or used drugs (prescription, addicting, illegal, pain pills, or drugs for addiction treatment) during pregnancy. Medicines the mother takes while pregnant, the baby also takes. Babies may experience withdrawal after delivery, and may need treatment. There are different ways to treat babies with withdrawal - about 50% of doctors use morphine, an opiate, to treat these babies, the rest uses other drugs, like clonidine and phenobarbitol.
Sponsor: University of Kentucky

Current Primary Outcome: Duration of treatment [ Time Frame: 3 months after discharge from hospital ]

Treatment for NAS started within first 7 days of life, continue until symptoms resolved. Slow decreases in dose are scheduled, and in most cases treatment is discontinued about 1 month after discharge


Original Primary Outcome: Same as current

Current Secondary Outcome: Evaluate the neurobehavioral performance scores (NNNS)in both treatment groups [ Time Frame: 5-10 days after treatment starts, and 1 month of age ]

The NNNS is Neonatal Intensive Care Network Neurobehavioral Scale, measures habituation, orientation, self regulation, motor/reflexes, and stress/abstinence scales


Original Secondary Outcome: Same as current

Information By: University of Kentucky

Dates:
Date Received: November 21, 2012
Date Started: September 2011
Date Completion: December 2014
Last Updated: October 20, 2014
Last Verified: October 2014