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

Completed · Phase 2

Conditions studied: Neonatal Abstinence Syndrome, Neonatal Withdrawal Syndrome

In brief

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).

Key facts

Study ID

NCT01708707

Run by

Pediatrix

People needed

29

Starts

2012-12-01

Expected to finish

2017-10-31

Last updated by the study team

2018-08-15

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Banner - University Medical Center Phoenix — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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