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NCT01965704 · ClinicalTrials.gov registry record · Phase 2
Can Ondansetron Prevent Neonatal Abstinence Syndrome (NAS) in Babies Born to Narcotic-dependent Women
A Phase 2 study, sponsored by Stanford University.
- Completed
- Registry status
- Phase 2
- Development phase
- 196
- Enrollment target
NCT01965704: Completed Phase 2 study, sponsored by Stanford University.
NCT01965704 is a Phase 2 study that has completed, run by Stanford University. The registered enrollment target is 196 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01965704, a Phase 2 study, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 196 participants
- Enrollment target
Study 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.
Primary Outcome
The incidence of neonatal abstinence syndrome (NAS) measured as the number of neonates who need for morphine treatment for the symptoms of neonatal opioid withdrawal syndrome (NOWS) while the neonates received study medication and for the 30 days after stopping the study medication.
Interventions
- DRUG Placebo
- DRUG Ondansetron
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 196 participants |
| Start Date | 2014-09-09 |
| Est. Completion | 2020-09-16 |
| Phase | Phase 2 |
What the finished NCT01965704 record still lists
NCT01965704 is an interventional study that assigns participants to a tested intervention. The registered 196 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01965704 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01965704 about?
NCT01965704 is a clinical study titled "Can Ondansetron Prevent Neonatal Abstinence Syndrome (NAS) in Babies Born to Narcotic-dependent Women". 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, plac...
What is the current status of trial NCT01965704?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 196 participants. The study started on 2014-09-09. Estimated completion is 2020-09-16.
What interventions are being tested in trial NCT01965704?
The interventions under investigation include: Placebo (DRUG), Ondansetron (DRUG).
Who is sponsoring clinical trial NCT01965704?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01965704's enrollment target sits among peer trials
196 349th of 2000 higher than 1,651 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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