Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pediatrix
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.
Age
0–1
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Infants of corrected gestational age ≥37 weeks
Chronic opioid exposure in utero
Signs and symptoms of NAS requiring treatment
2 consecutive Finnegan scores ≥8 or any single score ≥12
You may not be if
Concomitant maternal benzodiazepine or alcohol use 30 days prior to enrollment
Life-threatening congenital malformations
Intrauterine growth retardation
Seizure activity or congenital neurologic abnormalities
Concomitant neonatal use of Cytochrome P450 inhibitor or inducers prior to treatment
Inability of mother's consent due to altered mental status or comorbid psychiatric disorder
Neonatal administration of morphine prior to enrollment into study
