Can Ondansetron Prevent Neonatal Abstinence Syndrome (NAS) in Babies Born to Narcotic-dependent Women (AIM2NAS)
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 and their babies. 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 Investigators plan to give the pregnant narcotic-dependent mothers an intravenous dose of study medication prior to delivery and after the baby is born, the neonate 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 see if the baby had any symptoms of NAS.
Neonatal Abstinence Syndrome
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||AIM 2- Prevention of Neonatal Abstinence Syndrome|
- Incidence of neonatal abstinence syndrome [ Time Frame: 35 days ] [ Designated as safety issue: No ]The incidence of neonatal abstinence syndrome (NAS) will be measured by the need for pharmacologic treatment for the symptoms of NAS while the neonates are receiving study medication and for the 30 days after stopping the study medication.
- Severity of neonatal abstinence syndrome [ Time Frame: 35 days ] [ Designated as safety issue: No ]Severity of NAS will be measured by: the length of hospital stay (birth to discharge); the total dose of narcotic required to treat the symptoms of NAS; and the need to include barbiturates in the treatment of the symptoms of NAS.
|Study Start Date:||December 2013|
|Estimated Study Completion Date:||January 2017|
|Estimated Primary Completion Date:||November 2016 (Final data collection date for primary outcome measure)|
Pregnant Women: ondansetron 8mg intravenously (IV) within 4 hours of delivery. Neonates: ondansetron 0.1 mg/kg given orally every 24 hours starting 4-8 hours after delivery, for up to 5 days (if IV line available in neonate, ondansetron 0.07 mg/kg IV every 24 hours for up to 5 days).
Pregnant women may receive a second dose of IV ondansetron if they have not delivered within 4 hours of receiving the IV study medication. 50% of the 90 mother/baby pairs will receive ondansetron; the baby will always get the same study medication as the mother.
Other Name: Zofran
Placebo Comparator: Placebo
Pregnant Women: placebo given intravenously prior to delivery (volume to mimic the IV volume of the ondansetron group).
Neonates: placebo given orally every 24 hours, starting 4-8 hours after delivery, for up to 5 days with volume to mimic the oral volume of the ondansetron group (if IV line available, placebo may be given IV).
All doses of placebo, whether IV or oral, will mimic the same volume as the ondansetron group to maintain the blind. Pregnant women may receive a second dose of IV placebo if they have not delivered within 4 hours of being given the IV study medication. 50% of the 90 mother/baby pairs will receive placebo; the baby will always receive the same study medication as the mother.
Other Name: IV Normal saline; oral simple syrup
Investigators may obtain up to 9 pharmacokinetic (PK) blood samples from the neonates over 5 days when standard of care blood samples are drawn. These samples will consist of 1 to 2 drops of blood collected on filter paper and sent to Stanford for PK analysis. To protect the confidentiality of the patients (study subjects), the lead site, Stanford University, received a Certificate of Confidentiality from the NIH.
|Contact: Carol A Cohane, RNfirstname.lastname@example.org|
|United States, California|
|Stanford University Medical Center||Recruiting|
|Stanford, California, United States, 94305|
|Contact: Carol A Cohane|
|Principal Investigator: David R Drover, MD|
|Principal Investigator:||David R Drover, MD||Stanford University|