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NCT03396588 · ClinicalTrials.gov registry record · Phase 3
Non-Opiate Treatment After Prenatal Opiate Exposure to Prevent Postnatal Injury to the Young Brain
A Phase 3 study of Neonatal Abstinence Syndrome, sponsored by Henrietta Bada.
- Completed
- Registry status
- Phase 3
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT03396588 is a Phase 3 study of Neonatal Abstinence Syndrome that has completed, run by Henrietta Bada. The registered enrollment target is 120 participants, above the 59-participant average among 17 other Neonatal Abstinence Syndrome trials with a reported enrollment target (103% higher). The trial reports 1 study location across 1 state.
The verdict
NCT03396588, a Phase 3 study of Neonatal Abstinence Syndrome, has completed, sponsored by Henrietta Bada.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study Summary
The long term goals of our research are to establish the best pharmacological treatment for NAS and determine how pharmacologic treatment of NAS affects long-term developmental outcomes. The objective of this application is to evaluate the effectiveness of clonidine as a treatment for neonates with NAS, in a randomized clinical trial. Our central hypothesis is that clonidine will effectively treat drug withdrawal manifestations in neonates.
Conditions Studied
Interventions
- DRUG Morphine
- DRUG Clonidine
Study Locations (1)
Kentucky
- Kentucky Children's Hospital - Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2017-12-07 |
| Est. Completion | 2024-04-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03396588
The ClinicalTrials.gov registry entry for NCT03396588 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 59-participant average among 17 other Neonatal Abstinence Syndrome trials with a reported enrollment target (103% higher). The listed sponsor is Henrietta Bada, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Neonatal Abstinence Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Morphine is the first listed.
NCT03396588 reports 1 study location spanning 1 distinct geographic area - top geographies include Kentucky.
Frequently Asked Questions
What is clinical trial NCT03396588 about?
NCT03396588 is a clinical study titled "Non-Opiate Treatment After Prenatal Opiate Exposure to Prevent Postnatal Injury to the Young Brain". The long term goals of our research are to establish the best pharmacological treatment for NAS and determine how pharmacologic treatment of NAS affects long-term developmental outcomes. The objective of this application is to evaluate the effectiveness of clonidine as a treatment for neonates with ...
What is the current status of trial NCT03396588?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 120 participants. The study started on 2017-12-07. Estimated completion is 2024-04-10.
What conditions does trial NCT03396588 study?
This clinical trial studies the following conditions: Neonatal Abstinence Syndrome.
What interventions are being tested in trial NCT03396588?
The interventions under investigation include: Morphine (DRUG), Clonidine (DRUG).
Who is sponsoring clinical trial NCT03396588?
This trial is sponsored by Henrietta Bada, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03396588 being conducted?
This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Neonatal Abstinence Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
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Medication Treatment for Opioid Use Disorder in Expectant Mothers
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An Intervention Mapping Approach to Closing the Gap in Maternal OUD and Infant NAS Care (SUPPORT)
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Effective Caregiving for Neonatal Abstinence Syndrome: Testing an Instructional Mobile Technology Platform for High-Risk Pregnant Women
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Read our methodology - how this data is sourced, computed, and verified.
Related
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