Blinded Trial of Buprenorphine or Morphine in the Treatment of the Neonatal Abstinence Syndrome
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|ClinicalTrials.gov Identifier: NCT01452789|
Recruitment Status : Completed
First Posted : October 17, 2011
Results First Posted : March 24, 2020
Last Update Posted : March 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Neonatal Abstinence Syndrome||Drug: sublingual buprenorphine Drug: oral morphine||Phase 3|
This was a single-site, randomized, double-blind, double-dummy, parallel-group clinical trial. Potential patients were identified in the pre-natal period by staff of the Thomas Jefferson University Family center. Mothers who provided consent were contacted upon admission to TJUH. Inclusion and exclusion criteria were reassessed during the peri-partum period and study details reviewed again with the mother, and where possible, the father of the child. Women admitted to TJUH with in utero exposure to opioids who are not in the Family Center present were screened and approached for consent during their inpatient stay.
Infants at risk for NAS had abstinence assessed using the MOTHER scoring instrument, which is based upon Finnegan Score and will hereafter be called the "NAS score". This is the standard instrument used at TJUH. A need for initiation of treatment was defined as any consecutive 3 scores adding up to ≥ 24 or any single score ≥12, and the clinical decision of the attending physician that the infant requires pharmacologic therapy. Randomization took place following reaching of the threshold for initiation of treatment and a re-review of inclusion and exclusion criteria. Patients were randomized to treatment groups of 1) oral morphine/sublingual placebo for buprenorphine or 2) oral placebo for morphine/sublingual buprenorphine. Randomization was stratified according to in utero exposure to methadone or buprenorphine. Oral morphine or placebo for morphine was administered by mouth every 4 hours, while buprenorphine or placebo for buprenorphine was administered every 8 hours. NAS scores were obtained every 4 hours. Dose assessment took place on a daily basis. If the three previous NAS scores are greater than 24, a dose advancement took place (at the discretion of the neonatologist). Morphine/placebo will be increased by 20% and buprenorphine/placebo will be increased by 25%. NNNS scoring took place for all infants who provide consent at day 2-3 of life, or earlier if pharmacologic treatment is required before this time, on day 10 of life, and in the post therapy period (but no later than corrected post gestational age of 46 weeks).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Active-Control, Double-Blind, Double-Dummy Clinical Trial Comparing Sublingual Buprenorphine And Morphine Solution For The Treatment Of Neonatal Opioid Abstinence Syndrome|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2016|
Experimental: sublingual buprenorphine
This is the group that received active sublingual buprenorphine and placebo for oral morphine
Drug: sublingual buprenorphine
Initial daily dose: 15.9 mcg/kg/day; Initial unit dose: 5.3 mcg/kg q8 hours; Maximum daily dose: 60 mcg/kg/day; Up-titration rate: 25%; Weaning rate: 10%; Cessation Dose: Within 10 or 20% of starting dose
Other Name: Buprenex
Active Comparator: oral morphine
This is the group that received active oral morphine and placebo for sublingual buprenorphine
Drug: oral morphine
Initial daily dose: 0.4 mg/kg/day; Initial unit dose: 0.07 mg/kg q 4 hours; Maximum daily dose: 1.25 mg/kg/day; Up-titration rate: 20%; Weaning rate: 10%; Cessation Dose: 0.025 mg/kg q 4 hours
- Length of Treatment [ Time Frame: Patients will be followed for the duration of hospital stay, an expected average of 5 weeks. ]This endpoint will compare length of treatment (in days) using sublingual buprenorphine or oral morphine solution.
- Length of Hospitalization [ Time Frame: Duration of hospital stay is an expected average of 5 weeks. ]This endpoint will compare length of stay in the hospital (in days) using sublingual buprenorphine or morphine solution.
- Number of Patients Requiring Supplemental Phenobarbital Treatment. [ Time Frame: Patients will be followed for the duration of hospital stay, an expected average of 5 weeks. ]This endpoint will compare requirement number of patients who require use of supplemental phenobarbital.
- Number of Participants With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Patients will be followed for the duration of hospital stay, an expected average of 5 weeks. ]Adverse events will be collected, graded by severity, and assessed for causality referent to study drug.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01452789
|United States, Pennsylvania|
|Thomas Jefferson University Hosptial|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Walter K Kraft, MD||Thomas Jeffeson University|