Phase 2
N=196
Can Ondansetron Prevent Neonatal Abstinence Syndrome (NAS) in Babies Born to Narcotic-dependent Women
Narcotic Addiction · Neonatal Abstinence Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01965704 ↗Enrolled (actual)
196
Serious AEs
4.1%
Results posted
May 2022
Primary outcome: Primary: Number of Participants With Neonatal Abstinence Syndrome — 22; 26 Participants — p=0.2
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ondansetron (Drug); Placebo (Drug)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Neonatal Abstinence Syndrome |
22; 26 | 0.2 |
| SECONDARY Length of Hospital Stay |
15.5; 17.4; 9.3; 11.2 | 0.56 |
| SECONDARY Total Dose of Narcotic Required to Treat the Symptoms of NAS |
9.3; 11.1 | 0.31 |
| SECONDARY Number of Participants Requiring Adjunctive Medication to Treat NOWS |
5; 5 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 study).
- 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).
Exclusion Criteria
- 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 study.
- 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.
Data sourced from ClinicalTrials.gov (NCT01965704). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.