Can Ondansetron Prevent Neonatal Abstinence Syndrome (NAS) in Babies Born to Narcotic-dependent Women
Status:
Completed
Trial end date:
2021-06-30
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2
Details
Lead Sponsor:
Stanford University
Collaborators:
Johns Hopkins University Santa Clara Valley Medical Center Thomas Jefferson University University of California, San Francisco University of Louisville University of Tennessee Health Science Center University of Utah