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NCT01561079 · ClinicalTrials.gov registry record · Phase 2
Fetal and Infant Effects of Maternal Buprenorphine Treatment
A Phase 2 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 2
- Development phase
- 127
- Enrollment target
NCT01561079: Completed Phase 2 study, sponsored by Johns Hopkins University.
NCT01561079 is a Phase 2 study that has completed, run by Johns Hopkins University. The registered enrollment target is 127 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01561079, a Phase 2 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 127 participants
- Enrollment target
Study Summary
This research will track the longitudinal neurobehavioral development of the buprenorphine-exposed fetus across gestation through 1 month of age in an effort to determine the safety of this medication for use during gestation, the relationship between maternal physiologic changes due to buprenorphine administration and newborn functioning, and to determine potential fetal neurobehavioral markers that may predict Neonatal Abstinence Syndrome expression and infant neurobehavioral outcome. Comparisons to results from a similar project in methadone-exposed pregnancies will be made. This proposal seeks to advance the way the investigators inform the treatment of the opioid dependent woman during pregnancy and her infant after birth.
Primary Outcome
Fetal heart rate in beats per minute at time of trough and peak maternal buprenorphine levels
Interventions
- DRUG Buprenorphine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 127 participants |
| Start Date | 2012-02 |
| Est. Completion | 2016-06 |
| Phase | Phase 2 |
What the finished NCT01561079 record still lists
NCT01561079 is an interventional study that assigns participants to a tested intervention. The registered 127 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which Buprenorphine is the first listed.
NCT01561079 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01561079 about?
NCT01561079 is a clinical study titled "Fetal and Infant Effects of Maternal Buprenorphine Treatment". This research will track the longitudinal neurobehavioral development of the buprenorphine-exposed fetus across gestation through 1 month of age in an effort to determine the safety of this medication for use during gestation, the relationship between maternal physiologic changes due to buprenorphin...
What is the current status of trial NCT01561079?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 127 participants. The study started on 2012-02. Estimated completion is 2016-06.
What interventions are being tested in trial NCT01561079?
The interventions under investigation include: Buprenorphine (DRUG).
Who is sponsoring clinical trial NCT01561079?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01561079's enrollment target sits among peer trials
127 555th of 2000 higher than 1,445 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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