Status:
WITHDRAWN
Randomized Control Trial of Buprenorphine vs. Morphine for the Treatment of Neonatal Opioid Withdrawal Syndrome (NOWS)
Lead Sponsor:
Women and Infants Hospital of Rhode Island
Collaborating Sponsors:
National Institute of General Medical Sciences (NIGMS)
Conditions:
Neonatal Opioid Withdrawal Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 me...
Detailed Description
This randomized control trial will compare buprenorphine to morphine, two currently used medications for the treatment of NOWS, to determine whether the use of buprenorphine for NOWS treatment will re...
Eligibility Criteria
Inclusion
- 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
- 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
- The infant is not able to tolerate oral medication administration
- Multiple gestation pregnancy
- Hypoxic-ischemic encephalopathy
- Seizures from etiologies other than NOWS
- Non-English Speaking
- Infant started on NOWS standard care medication prior to study consent
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 17 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04455802
Start Date
October 1 2020
End Date
May 17 2021
Last Update
June 22 2023
Active Locations (1)
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1
Women and Infants Hospital
Providence, Rhode Island, United States, 02905