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

Who is this study for? Infant patients with Neonatal Abstinence Syndrome
What treatments are being studied? Clonidine
Status: Active_not_recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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 .

Eligibility
Participation Requirements
Sex: All
Maximum Age: 10 days
Healthy Volunteers: f
View:

• Born at Cooper University Hospital

• Greater than or equal to 35 weeks gestation age

• Admitted to the NICU or Transitional nursery

• Mothers admitted to using illicit substances or prescription medications (which can result in withdrawal symptoms) while pregnant and/or had a positive urine drug screen during pregnancy.

• Babies being started on medication to control withdrawal symptoms of NAS.

• No congenital anomalies or neurologic condition (i.e. hypoxic-ischemic encephalopathy, seizures, meningitis etc.)

Locations
United States
New Jersey
Cooper University Hospital
Camden
Time Frame
Start Date: 2018-02-21
Completion Date: 2026-12-01
Participants
Target number of participants: 69
Treatments
Experimental: Clonidine
Clonidine at 0.38 mcg/kg/dose every 3 hours or 0.5 mcg/kg/dose every 4 hours
Active_comparator: Morphine
Morphine Sulfate at 0.03 mg/kg/dose every 3 hours or 0.04 mg/kg/dose every 4 hours
Related Therapeutic Areas
Sponsors
Leads: The Cooper Health System

This content was sourced from clinicaltrials.gov