NCT01734551

NAS Treatment - Opiate Versus Non-Opiate

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Henrietta Bada · Academic / Other
• Sex: All
• Age: 1 Day – 7 Days
• Healthy volunteers: Not accepted

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 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.

Conditions

• Neonatal Abstinence Syndrome

Interventions

Type	Name	Description
DRUG	Morphine	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.
DRUG	Clonidine	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.

Timeline

• Start date: 2011-09-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2012-11-27
• Last updated: 2017-09-12
• Results posted: 2017-09-12

Locations

1 site across 1 country: United States