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

Phase 2

Completed

• Conditions: Neonatal Abstinence Syndrome; Neonatal Withdrawal Syndrome
• Interventions: Drug: Morphine Sulfate; Drug: Buprenorphine

• Registration Number: NCT01708707
• Lead Sponsor: Pediatrix

Brief 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).

Detailed Description

Neonatal abstinence syndrome is a condition that affects newborns who are exposed to chronic opioid drugs while they are in a mother's uterus (womb) prior to birth. The current standard of care treatment includes morphine sulfate. Buprenorphine is a drug used in adults to treat narcotic dependence and withdrawal, but has not yet been approved for use in newborns as a treatment alternative for Neonatal Abstinence Syndrome. This investigation is designed to measure if sublingual (under the tongue) buprenorphine is able to reduce hospital length of stay and decrease number of days of drug treatment currently required in treatment of NAS. Another goal will be to understand buprenorphine as a cost effective treatment for NAS.

Study Timeline

• Study First Submitted: 2012-04-25
• Study First Submitted QC: 2012-10-15
• Study First Posted: 2012-10-17
• Study Start: 2012-12
• Primary Completion: 2017-10
• Study Completion: 2017-10-31
• Status Verified: 2018-03
• Last Update Submitted: 2018-08-14
• Last Update Posted: 2018-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral morphine sulfate	Morphine Sulfate	Oral morphine sulfate 0.4 mg/kg/day morphine every 3-4 hours as needed for Finnegan scores suggestive of Neonatal Abstinence Syndrome Other Name: morphine
Buprenorphine	Buprenorphine	Sublingual Buprenorphine 15.9 µg/kg per day in 3 divided doses, titrated up or escalated down based upon standardized scoring for neonatal abstinence syndrome

Primary Outcome Measures

Name	Time	Method
Hospital length of stay	Up to hospital discharge, an anticipated average of 4 weeks	Number of days of hospital admission

Secondary Outcome Measures

Name	Time	Method
Number of adverse or serious adverse events	Up to hospital discharge, with length of stay currently averaging approximately 4 weeks
Cost efficiency of buprenorphine	At least 48 prior to hospital discharge, with anticipated discharge averaging to be 4 weeks	Cost of buprenorphine as a product of number of days of administration
Withdrawal symptoms	Up to hospital discharge, usually occuring on average 4 weeks	Finnegan methodology to score withdrawal symptoms every four hours of medication administration
Rescue dosage administration	Up to hospital discharge, anticipating an average of 4 weeks	Number of rescue doses of additional medication

Trial Locations

Locations (1)

Banner - University Medical Center Phoenix; 🇺🇸 Phoenix, Arizona, United States