Buprenorphine for Treatment of Neonatal Abstinence Syndrome in Infants With In Utero Exposure to Benzodiazepines
- Conditions
- Neonatal Abstinence Syndrome
- Interventions
- Registration Number
- NCT01671410
- Lead Sponsor
- Thomas Jefferson University
- Brief Summary
The opioid neonatal abstinence syndrome (NAS) is a condition of withdrawal symptoms after utero exposure to opioids. Sublingual buprenorphine shows promise as a new treatment in NAS. This trial will investigate the safety and tolerability of sublingual buprenorphine in infants exposed to both opioids and benzodiazepines in utero or with exposure of opioids in those who are breastfeeding.
- Detailed Description
Infants with in utero exposure to opioids often require therapy with morphine for an extended period. In a clinical trial, sublingual buprenorphine reduced this treatment period by \~30%. However, infants with both opioid and benzodiazepine exposure were not included in the trial. This study will test the safety and tolerability of sublingual buprenorphine in infants with in utero exposure to benzodiazepines or who are breastfeeding.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 11
- ≥ 37 weeks gestation
- Exposure to opioids in utero
- Demonstration of signs and symptoms of neonatal abstinence syndrome requiring treatment
- Exposure to benzodiazepines in utero and/or receiving breast milk. Benzodiazepine use is defined as maternal use in the past 30 days, and/or receipt of benzodiazepines by prescription (as determined by self-report or intake urine) by the mother 30 days prior to birth.
- Major congenital malformations and/or intrauterine growth retardation defined as birth weight <2200 gm
- Medical illness requiring intensification of medical therapy. This includes, but is not limited to suspected sepsis requiring antibiotic therapy.
- Hypoglycemia requiring treatment with intravenous dextrose
- Bilirubin >20 mg/dL (The need for phototherapy is not exclusionary)
- Seizure activity or other neurologic abnormality
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description sublingual buprenorphine 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 oral morphine 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
- Primary Outcome Measures
Name Time Method Length of treatment 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.
- Secondary Outcome Measures
Name Time Method Length of hospitalization Patients will be followed for the duration of hospital stay, an expected average of 5 weeks This endpoint will compare length of stay (in days) using sublingual buprenorphine or oral morphine
Number of patients requiring supplemental phenobarbital treatment 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 for treatment of NAS
Number of participants with adverse events as a measure of safety and tolerability 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.
Trial Locations
- Locations (1)
Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States