Comparison of Buprenorphine to Morphine in Treatment of Neonatal Abstinence Syndrome (NAS)

• Status: Completed
• Trial end date: 2017-10-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to determine whether buprenorphine is a beneficial, safe, cost effective treatment alternative to morphine sulfate in the treatment of Neonatal Abstinence Syndrome (NAS).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mednax Center for Research, Education and Quality; Mednax Center for Research, Education, Quality and Safety
• Treatments: Buprenorphine; Morphine

Criteria

Inclusion Criteria:

• Infants of corrected gestational age ≥37 weeks

• Chronic opioid exposure in utero

• Signs and symptoms of NAS requiring treatment

• 2 consecutive Finnegan scores ≥8 or any single score ≥12

Exclusion Criteria:

• Concomitant maternal benzodiazepine or alcohol use 30 days prior to enrollment

• Life-threatening congenital malformations

• Intrauterine growth retardation

• Seizure activity or congenital neurologic abnormalities

• Concomitant neonatal use of Cytochrome P450 inhibitor or inducers prior to treatment

• Inability of mother's consent due to altered mental status or comorbid psychiatric disorder

• Neonatal administration of morphine prior to enrollment into study