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NCT01958476 · ClinicalTrials.gov registry record · Phase 3
Improving Outcomes in Neonatal Abstinence Syndrome
A Phase 3 study, sponsored by Tufts Medical Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 117
- Enrollment target
NCT01958476: Completed Phase 3 study, sponsored by Tufts Medical Center.
NCT01958476 is a Phase 3 study that has completed, run by Tufts Medical Center. The registered enrollment target is 117 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01958476, a Phase 3 study, has completed, sponsored by Tufts Medical Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 117 participants
- Enrollment target
Study Summary
1: SPECIFIC Aim I: To compare treatment options for neonatal abstinence syndrome (NAS) due to in-utero narcotic exposure. One hundred eighty four full-term infants with a diagnosis of NAS requiring medications will be studied. Infants will be randomized to receive either morphine or methadone. It is hypothesized that morphine treated infants will do better and require fewer days in the hospital compared to methadone treated infants. 2\. SPECIFIC Aim II: To evaluate the effects of NAS treatment on long-term neurodevelopmental outcome. Infants will be evaluated with development testing at 18 months of age. It is hypothesized that morphine treated infants will have better neurodevelopmental outcomes. It is also hypothesized that neurobehavioral abnormalities identified at two weeks of age will correlate with neurodevelopmental impairment at 18 months. 3: SPECIFIC Aim III: To determine if common genetic variations in the genes involving narcotic action contribute to the severity of NAS. A DNA sample will be obtained from all infants and analyzed for differences in 3 key genes. This will then be correlated with short-term and long-term outcomes.
Primary Outcome
Participants were monitored for the duration of their hospitalization, an expected mean of 22 days.
Interventions
- DRUG Methadone
- DRUG Phenobarbital
- DRUG Neonatal Morphine Solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 117 participants |
| Start Date | 2013-09 |
| Est. Completion | 2018-08-30 |
| Phase | Phase 3 |
What the finished NCT01958476 record still lists
NCT01958476 is an interventional study that assigns participants to a tested intervention. The registered 117 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 3 interventions - of which Methadone is the first listed.
NCT01958476 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01958476 about?
NCT01958476 is a clinical study titled "Improving Outcomes in Neonatal Abstinence Syndrome". 1: SPECIFIC Aim I: To compare treatment options for neonatal abstinence syndrome (NAS) due to in-utero narcotic exposure. One hundred eighty four full-term infants with a diagnosis of NAS requiring medications will be studied. Infants will be randomized to receive either morphine or methadone. It is...
What is the current status of trial NCT01958476?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 117 participants. The study started on 2013-09. Estimated completion is 2018-08-30.
What interventions are being tested in trial NCT01958476?
The interventions under investigation include: Methadone (DRUG), Phenobarbital (DRUG), Neonatal Morphine Solution (DRUG).
Who is sponsoring clinical trial NCT01958476?
This trial is sponsored by Tufts Medical Center, which has 169 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01958476's enrollment target sits among peer trials
117 1642nd of 2000 higher than 358 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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