Clonidine Versus Phenobarbital as Adjunctive Therapy for Neonatal Abstinence Syndrome

PHASE2CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

October 1, 2018

Primary Completion Date

May 31, 2020

Study Completion Date

May 31, 2020

Conditions
Neonatal Abstinence Syndrome
Interventions
DRUG

Phenobarbital

Phenobarbital loading dose 20 mg/kg in 2 divided doses, then 5 mg/kg/day divided every 12 hours. Phenobarbital dose will be adjusted to obtain desired trough of 25 to 30 mcg/mL. Levels will be obtained on Day 6 then weekly thereafter. Phenobarbital will be tapered over 4 weeks upon discharge from the hospital. The standardized taper is based the patient specific dose at the time of discharge.

DRUG

Clonidine

Clonidine 5 mcg/kg/day divided every 3 hours. Clonidine will be increased by 1.5 mcg/kg/day to achieve control of NAS symptoms based upon standardized scoring for neonatal abstinence syndrome. Clonidine will be weaned by 25% every 24 hours after successful discontinuation of oral morphine sulfate. Infants will not be discharged on clonidine.

Trial Locations (1)

37920

University of Tennessee Medical Center, Knoxville

All Listed Sponsors
lead

University of Tennessee Medical Center

OTHER

NCT03670160 - Clonidine Versus Phenobarbital as Adjunctive Therapy for Neonatal Abstinence Syndrome | Biotech Hunter | Biotech Hunter