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NCT01598259 · ClinicalTrials.gov registry record · Phase 2
Randomized Controlled Trial to Assess Efficacy of Melatonin for Children During Burn Rehabilitation
A Phase 2 study, sponsored by Shriners Hospitals for Children.
- Terminated
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT01598259: Clinical Trial Phase 2 study, sponsored by Shriners Hospitals for Children.
NCT01598259 is a Phase 2 study that was terminated before completion, run by Shriners Hospitals for Children. The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01598259, a Phase 2 study, was terminated before completion, sponsored by Shriners Hospitals for Children.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study Summary
The specific aims of this investigation in children during burn rehabilitation include 1.) to determine the efficacy of melatonin intervention on improving sleep-related outcomes 2.) investigate the hypothesis that sleep inadequacy is associated with cognitive deficits and 3.) develop a new methodology specific for burn patients that accurately screens for the presence of intrinsic dyssomnia.
Primary Outcome
Measure sleep parameters via polysomnography, actigraphy and urinary melatonin
Interventions
- DRUG Melatonin
- OTHER placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2014-05 |
| Est. Completion | 2016-06 |
| Phase | Phase 2 |
Why NCT01598259 stopped before completion
NCT01598259 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Melatonin is the first listed.
NCT01598259 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01598259 about?
NCT01598259 is a clinical study titled "Randomized Controlled Trial to Assess Efficacy of Melatonin for Children During Burn Rehabilitation". The specific aims of this investigation in children during burn rehabilitation include 1.) to determine the efficacy of melatonin intervention on improving sleep-related outcomes 2.) investigate the hypothesis that sleep inadequacy is associated with cognitive deficits and 3.) develop a new methodol...
What is the current status of trial NCT01598259?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2014-05. Estimated completion is 2016-06.
What interventions are being tested in trial NCT01598259?
The interventions under investigation include: Melatonin (DRUG), placebo (OTHER).
Who is sponsoring clinical trial NCT01598259?
This trial is sponsored by Shriners Hospitals for Children, which has 40 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01598259's enrollment target sits among peer trials
10 1968th of 2000 higher than 12 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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