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

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: A Randomized Comparison of Sublingual Buprenorphine to Morphine Sulfate in the Treatment of Neonatal Abstinence Syndrome (NAS)

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 Summary: 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.
Sponsor: Mednax Center for Research, Education and Quality

Current Primary Outcome: Hospital length of stay [ Time Frame: Up to hospital discharge, an anticipated average of 4 weeks ]

Number of days of hospital admission


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of adverse or serious adverse events [ Time Frame: Up to hospital discharge, with length of stay currently averaging approximately 4 weeks ]
  • Cost efficiency of buprenorphine [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Up to hospital discharge, anticipating an average of 4 weeks ]
    Number of rescue doses of additional medication


Original Secondary Outcome: Same as current

Information By: Mednax Center for Research, Education and Quality

Dates:
Date Received: April 25, 2012
Date Started: December 2012
Date Completion: June 2017
Last Updated: March 29, 2016
Last Verified: March 2016