Randomized Control Trial of Buprenorphine vs. Morphine for the Treatment of Neonatal Opioid Withd… (NCT04455802) | Clinical Trial Compass
WithdrawnPhase 3
Randomized Control Trial of Buprenorphine vs. Morphine for the Treatment of Neonatal Opioid Withdrawal Syndrome (NOWS)
Stopped: termination of funding
United States0Started 2020-10-01
Plain-language summary
This randomized control trial will compare buprenorphine and morphine, two currently used medications for the treatment of neonatal opioid withdrawal syndrome (NOWS), in newborns to determine which medication will reduce the number of days of pharmacological treatment.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Infant gestational age greater than or equal 36 weeks
✓. Mother receiving either methadone from a drug treatment program, buprenorphine from a licensed physician, or an opioid prescription for a documented medical need
✓. Mother had at least 2 prenatal appointments.
✓. Infant toleration of oral medication administration
✓. Infant is considered medically stable by the attending physician
✓. Singleton Pregnancy
✓. English Speaking
Exclusion criteria
✕. Within 30 days of birth the mother has actively used illicit drugs (excluding THC) or obtaining oral opioids, methadone, or buprenorphine from a non-licensed physician or drug treatment program
✕. The mother has had less than 2 prenatal care visits
✕. The mother reports excessive alcohol use during pregnancy
✕. Mother is less than 18 years of age or is not capable of signing consent
✕. The infant has a gestational age less than or equal to 35 weeks and 6 days
✕. The infant has dysmorphic features including evidence of aneuploidy
What they're measuring
1
Total amount of opioid medication for treatment of NOWS
Timeframe: Duration of pharmacological treatment with opioid medication while admitted to the hospital up to 30 days