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NCT04298853 · ClinicalTrials.gov registry record · Phase 4
Optimal Morphine Dosing Schedule for Neonatal Abstinence Syndrome
A Phase 4 study of Neonatal Abstinence Syndrome and Neonatal Opioid Withdrawal Syndrome, sponsored by Indiana University.
- Completed
- Registry status
- Phase 4
- Development phase
- 17
- Enrollment target
- 1
- Study location
NCT04298853: Completed Phase 4 study of Neonatal Abstinence Syndrome and Neonatal Opioid Withdrawal Syndrome, sponsored by Indiana University.
NCT04298853 is a Phase 4 study of Neonatal Abstinence Syndrome and Neonatal Opioid Withdrawal Syndrome that has completed, run by Indiana University. The registered enrollment target is 17 participants, below the 66-participant average among 17 other Neonatal Abstinence Syndrome trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04298853, a Phase 4 study of Neonatal Abstinence Syndrome and Neonatal Opioid Withdrawal Syndrome, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 17 participants
- Enrollment target
- 1
- Study location
Study Summary
Randomized pilot trial comparing scheduled morphine dosing with a weaning protocol to intermittent morphine dosing on an as-needed basis for newborns with neonatal abstinence syndrome.
Primary Outcome
Percentage of eligible subjects who were enrolled and randomized in the study
Conditions Studied
Interventions
- DRUG Morphine PRN
- DRUG Morphine scheduled
Study Locations (1)
Indiana
- Indiana University Health Methodist Hospital - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2020-06-30 |
| Est. Completion | 2021-10-01 |
| Phase | Phase 4 |
What the finished NCT04298853 record still lists
NCT04298853 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 66-participant average among 17 other Neonatal Abstinence Syndrome trials with a reported enrollment target (74% lower).
The record links to 3 conditions, with Neonatal Abstinence Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Morphine PRN is the first listed.
NCT04298853 reports a single indexed study location in Indiana.
Frequently Asked Questions
What is clinical trial NCT04298853 about?
NCT04298853 is a clinical study titled "Optimal Morphine Dosing Schedule for Neonatal Abstinence Syndrome". Randomized pilot trial comparing scheduled morphine dosing with a weaning protocol to intermittent morphine dosing on an as-needed basis for newborns with neonatal abstinence syndrome.
What is the current status of trial NCT04298853?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 17 participants. The study started on 2020-06-30. Estimated completion is 2021-10-01.
What conditions does trial NCT04298853 study?
This clinical trial studies the following conditions: Neonatal Abstinence Syndrome, Neonatal Opioid Withdrawal Syndrome, Neonatal Opioid Withdrawal.
What interventions are being tested in trial NCT04298853?
The interventions under investigation include: Morphine PRN (DRUG), Morphine scheduled (DRUG).
Who is sponsoring clinical trial NCT04298853?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04298853 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04298853's enrollment target sits among peer trials
17 17th of 17 higher than 1 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.
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