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Neonatal abstinence syndrome is a disease that affects children who were exposed to opioid drugs prior to birth. Commonly used treatments at present include morphine or tincture of opium. Buprenorphine is a drug used in adults to treat narcotic dependence, but has not been used for Neonatal Abstinence Syndrome. This trial is designed to see if the use of sublingual (under the tongue) buprenorphine is able to be used safely and easily in newborns with the neonatal abstinence syndrome. Secondary goals will be to see if treatment with buprenorphine is associated shorter stays in the hospital and fewer days of treatment than the use of standard therapy. Another secondary goal will be to understand buprenorphine concentration in the blood of babies treated with the drug (this is called "pharmacokinetics").
Age
All ages
Sex
ALL
Healthy Volunteers
No
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Start Date
April 1, 2004
Primary Completion Date
January 1, 2010
Completion Date
January 1, 2010
Last Updated
January 12, 2017
60
ESTIMATED participants
buprenorphine
DRUG
Oral morphine solution
DRUG
Lead Sponsor
Thomas Jefferson University
Collaborators
NCT04783558
NCT05129020
Data Source & Attribution
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