NCT03396588View on ClinicalTrials.gov

Non-Opiate Treatment After Prenatal Opiate Exposure to Prevent Postnatal Injury to the Young Brain

PHASE3CompletedINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

December 7, 2017

Primary Completion Date

April 10, 2024

Study Completion Date

April 10, 2024

Conditions
Neonatal Abstinence Syndrome
Interventions
DRUG

Clonidine

1mcg/kg/dose (with a dosing interval of 3 or 4 hours), increases by 25% of initial dose every 12-24 hrs. Decrease by 10% of max dose every 24 hrs.

DRUG

Morphine

Starting dose is 0.06 mg/kg/dose (every 3 or 4 hours), increases by 25% of initial dose every 12-24 hrs. Decrease by 10% of max dose every 24 hrs.

Trial Locations (1)

40536

Kentucky Children's Hospital, Lexington

All Listed Sponsors
collaborator

National Institute on Drug Abuse (NIDA)

NIH

lead

Henrietta Bada

OTHER

NCT03396588 - Non-Opiate Treatment After Prenatal Opiate Exposure to Prevent Postnatal Injury to the Young Brain | Biotech Hunter | Biotech Hunter