Clinical Trial: Buprenorphine for Treatment of Neonatal Abstinence Syndrome in Infants With In Utero Exposure to Benzodiazepines

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Open Label Clinical Trial of Buprenorphine in the Treatment of Neonatal Abstinence Syndrome in Infants With In Utero Exposure to Benzodiazepines or Are Breas

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 Summary: 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.
Sponsor: Thomas Jefferson University

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Length of hospitalization [ Time Frame: 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 [ 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 for treatment of NAS
  • 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.


Original Secondary Outcome: Same as current

Information By: Thomas Jefferson University

Dates:
Date Received: August 20, 2012
Date Started: August 2012
Date Completion:
Last Updated: October 13, 2016
Last Verified: October 2016