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ACTIVE NOT RECRUITING
NCT03092011
PHASE4

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

Sponsor: The Cooper Health System

View on ClinicalTrials.gov

Summary

The purpose of this study is to show non-inferiority between two medications used for medical treatment of withdrawal seen in Neonatal Abstinence Syndrome (NAS), Clonidine and Morphine Sulfate (used in routine care) on length of treatment for NAS .

Key Details

Gender

All

Age Range

Any - 10 Days

Study Type

INTERVENTIONAL

Enrollment

69

Start Date

2018-02-21

Completion Date

2026-12-01

Last Updated

2024-10-15

Healthy Volunteers

No

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.

Locations (1)

Cooper University Hospital

Camden, New Jersey, United States