Clinical trial NCT01708707: Comparison of Buprenorphine to Morphine in Treatment of Neonatal Abstinence Syndrome (NAS)
Official title: A Randomized Comparison of Sublingual Buprenorphine to Morphine Sulfate in the Treatment of Neonatal Abstinence Syndrome (NAS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neonatal Abstinence Syndrome
Neonatal Withdrawal Syndrome
Lead sponsor: Pediatrix
Sponsor class: OTHER
First posted: 2012-10-17
Enrollment: 29
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Hospital length of stay
timeFrame: Up to hospital discharge, an anticipated average of 4 weeks
Secondary outcomes:
measure: Number of adverse or serious adverse events
timeFrame: Up to hospital discharge, with length of stay currently averaging approximately 4 weeks
measure: Cost efficiency of buprenorphine
timeFrame: At least 48 prior to hospital discharge, with anticipated discharge averaging to be 4 weeks
measure: Withdrawal symptoms
timeFrame: Up to hospital discharge, usually occuring on average 4 weeks
measure: Rescue dosage administration
timeFrame: Up to hospital discharge, anticipating an average of 4 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner - University Medical Center Phoenix
state: Arizona
Study officials:
affiliation: Banner University Medical Center
name: Gregory Martin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zankl A, Martin J, Davey JG, Osborn DA. Opioid treatment for opioid withdrawal in newborn infants. Cochrane Database Syst Rev. 2021 Jul 7;7(7):CD002059. doi: 10.1002/14651858.CD002059.pub4.