Overview

This trial is active, not recruiting.

Condition neonatal abstinence syndrome
Treatments morphine, clonidine
Phase phase 4
Sponsor University of Kentucky
Start date September 2011
End date December 2014
Trial size 34 participants
Trial identifier NCT01734551, 11-0534

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Initial dose is 0.4mg/kg/day, divided every 3-4 hours, given PO with feeds. Drug is required until symptoms of withdrawal no longer cause the infant feeding, behavior, or elimination problems, up to 3 months.
morphine Morphine sulfate
Start at 0.4mg/kg/day (divided every 3-4 hours, given with feeds. Dose may be increased 25% of initial dose until symptoms are stable, up to 1 mg/kg/day. Once stable for 72 hrs, weaning may begin (decrease 10% of max dose, every other day). When total dose is <0.1mg/kg/day, may discontinue.
(Active Comparator)
Dose is started at 5 mcg/kg/day, given PO with feeds, divided every 3-4 hours. Drug is required until symptoms of withdrawal no longer cause the infant feeding, behavior, or elimination problems, up to 3 months.
clonidine clonidine hydrochloride
Initial dose is 5 mcg/kg/day (divided every 3-4 hrs, given with feeds). Will increase 25% of initial dose every 12-24 hrs until stable, up to 12 mcg/kg/day. Dose is unchanged for 72 hours once stable, then may decrease by 10% every other day. If re-escalation is required, the previous dose may be used with 72 hours for stabilizing.

Primary Outcomes

Measure
Duration of treatment
time frame: 3 months after discharge from hospital

Secondary Outcomes

Measure
Evaluate the neurobehavioral performance scores (NNNS)in both treatment groups
time frame: 5-10 days after treatment starts, and 1 month of age

Eligibility Criteria

Male or female participants up to 7 days old.

Inclusion Criteria: - Admitted to Neonatal Intensive Care Unit (NICU)- Gestational age (GA) >or= 35 wks - Known prenatal opiate exposure (maternal history, positive opiate screen, positive neonatal urine or meconium screen) - Symptomatic with Finnegan Neonatal Abstinence Scores meeting NICU protocol for treatment Exclusion Criteria: - Seizures - Major congenital malformations - Unlikely to survive - Parents not able to understand English

Additional Information

Official title Pharmacological Treatment of Neonatal Abstinence Syndrome: Opiate Versus Non-Opiate
Principal investigator Henrietta S Bada, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2014.
Information provided to ClinicalTrials.gov by University of Kentucky.