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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: Completed Phase 3 study of Neonatal Abstinence Syndrome, sponsored by Henrietta Bada.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The summary scores from the Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS) give a measure of infant neurobehavior in the following areas (score range): habituation (1-9), regulation (2.20-7.50), attention (1.29-8.4), Handling (0-1), quality of movement (1.20-6.20), Non-optimal reflexes (0-12), Asymmetric reflexes (0-7), arousal (2.43-6.67), hypertonicity (0-8), hypotonicity (0-5.0), excitability (0-11), lethargy (0-11.0), and stress/abstinence (0-0.57). A higher score for each
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 |
What the finished NCT03396588 record still lists
NCT03396588 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, above the 59-participant average among 17 other Neonatal Abstinence Syndrome trials with a reported enrollment target (103% higher).
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 a single indexed study location in 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.
Where NCT03396588's enrollment target sits among peer trials
120 2nd of 17 the highest of 17 other Neonatal Abstinence Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neonatal Abstinence Syndrome 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
-
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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-
Treatment of Neonatal Abstinence Syndrome With Clonidine Versus Morphine as Primary Therapy
ACTIVE NOT RECRUITING · Phase 4
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