Overview

Randomized Control Trial of Buprenorphine vs. Morphine for the Treatment of Neonatal Opioid Withdrawal Syndrome (NOWS)

Status:
Not yet recruiting
Trial end date:
2024-08-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Women and Infants Hospital of Rhode Island
Collaborator:
National Institute of General Medical Sciences (NIGMS)
Treatments:
Buprenorphine
Morphine
Criteria
Inclusion Criteria:

1. Infant gestational age greater than or equal 36 weeks

2. Mother receiving either methadone from a drug treatment program, buprenorphine from a
licensed physician, or an opioid prescription for a documented medical need

3. Mother had at least 2 prenatal appointments.

4. Infant toleration of oral medication administration

5. Infant is considered medically stable by the attending physician

6. Singleton Pregnancy

7. English Speaking

Exclusion Criteria:

1. 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

2. The mother has had less than 2 prenatal care visits

3. The mother reports excessive alcohol use during pregnancy

4. Mother is less than 18 years of age or is not capable of signing consent

5. The infant has a gestational age less than or equal to 35 weeks and 6 days

6. The infant has dysmorphic features including evidence of aneuploidy

7. The infant is not able to tolerate oral medication administration

8. Multiple gestation pregnancy

9. Hypoxic-ischemic encephalopathy

10. Seizures from etiologies other than NOWS

11. Non-English Speaking

12. Infant started on NOWS standard care medication prior to study consent