Treatment of Neonatal Abstinence Syndrome With Clonidine Versus Morphine as Primary Therapy

PHASE4Active, not recruitingINTERVENTIONAL
Enrollment

69

Participants

Timeline

Start Date

February 21, 2018

Primary Completion Date

October 1, 2024

Study Completion Date

December 1, 2026

Conditions
Neonatal Abstinence Syndrome
Interventions
DRUG

Clonidine

Clonidine at 0.38 mcg/kg/dose every 3 hours or 0.5 mcg/kg/dose every 4 hours Clonidine dose will be increased by 25% of the previous dose if needed. It will be decreased by 10% of the highest dose using the original/birth weight (same amount each time) every 24 to 48 hours, provided the scores remain below 8.

DRUG

Morphine Sulfate

Morphine at 0.03 mg/kg/dose every 3 hours or 0.04 mg/kg/dose every 4 hours Morphine dose will be increased by 25% of the previous dose if needed. It will be decreased by 10% of the highest dose using the original/birth weight (same amount each time) every 24 to 48 hours, provided the scores remain below 8.

Trial Locations (1)

08103

Cooper University Hospital, Camden

All Listed Sponsors
lead

The Cooper Health System

OTHER