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Can Ondansetron Prevent Neonatal Abstinence Syndrome (NAS) in Babies Born to Narcotic-dependent Women
Trial ID: NCT01965704
The Investigators hope to learn if they can prevent or lessen the symptoms of neonatal abstinence syndrome (NAS) in babies born to narcotic-dependent mothers by using the drug ondansetron in the mothers prior to delivery and their babies after delivery. The study is a randomized, double-blind, placebo-controlled study with one half the mother-baby pairs to receive ondansetron and the other half of the mother-baby pairs to receive placebo. The pregnant narcotic-dependent mothers will receive an intravenous dose of study medication prior to delivery; the neonates, after their birth, will receive the same study medication the mother received every 24 hours for up to 5 days. The Investigators will follow up with the mother-baby pairs for 10 days after study drug has stopped and one last follow up, about 30 days after stopping study drug, to learn if the baby had any symptoms of NAS in that time period.
AIM 2- Prevention of Neonatal Abstinence Syndrome
- adult female, opioid-dependent for at least 3 weeks prior to delivery.
- adult female, otherwise healthy.
- adult female, age 18-45 years inclusive.
- adult female, signed consent to participate for self and neonate (maternal subject may
decide not to receive the study drug but her neonate can still be included in the
- neonate, gestational age 37 weeks through 41 weeks and 6 days at birth.
- neonate, corrected QT interval (QTc) from 12-lead electrocardiogram (ECG) less than
480 milliseconds (ms).
- adult female, any condition that, in the opinion of the investigator, would compromise
the health of the participant (both mother and fetus) or the integrity of the data.
- adult female, known allergy to study drug (ondansetron).
- adult female, screening 12-lead ECG, if done, showing prolonged QTc will stop the
mother from receiving any study drug but her neonate can still be included in the
- adult female, not dependent on opioids for at least 3 weeks prior to delivery.
- adult female, generally not healthy.
- adult female, age 17 years or less or 46 years of age and older.
- adult female and neonate, the maternal ingestion or administration of ondansetron
within 24 hours prior to delivery, for reasons other than study purposes, will exclude
the mother and the neonate.
- neonate, preterm or post-term gestational age at delivery.
- neonate, QTc showing results greater than or equal to 480ms on any 12-lead ECG post
delivery will stop the dosing of the study drug, but safety follow up will be done if
the mother or baby received at least one dose of study drug.
School of Medicine
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Carol A Cohane, RN