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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 is a Phase 3 study that has completed, run by Tufts Medical Center. The registered enrollment target is 117 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01958476
The ClinicalTrials.gov registry entry for NCT01958476 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 117 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tufts Medical Center, which has 169 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Methadone is the first listed.
NCT01958476 reports 0 study locations.
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.
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