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Treatment of Neonatal Abstinence Syndrome With Clonidine Versus Morphine as Primary Therapy
Sponsor: The Cooper Health System
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
Conditions
Interventions
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.
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