NAS Treatment - Opiate Versus Non-Opiate

PHASE4CompletedINTERVENTIONAL
Enrollment

31

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

December 31, 2014

Study Completion Date

December 31, 2014

Conditions
Neonatal Abstinence Syndrome
Interventions
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.

Trial Locations (1)

40536

University of Kentucky Medical Center, Lexington

All Listed Sponsors
lead

Henrietta Bada

OTHER

NCT01734551 - NAS Treatment - Opiate Versus Non-Opiate | Biotech Hunter | Biotech Hunter