NCT01598259
Terminated
Phase 2
Randomized Controlled Trial to Assess Efficacy of Melatonin for Children During Burn Rehabilitation
Overview
- Phase
- Phase 2
- Intervention
- Melatonin
- Conditions
- Burns
- Sponsor
- Shriners Hospitals for Children
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- sleep
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
Brief 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.
Investigators
Michele Gottschlich
Research Scientist
Shriners Hospitals for Children
Eligibility Criteria
Inclusion Criteria
- •History of burn injury
- •Scheduled for an elective surgical procedure
- •5 - 22 years of age, inclusive
Exclusion Criteria
- •History of anoxic brain injury
- •History of head injury within the last year
- •Pre-existing seizure disorder
- •Pre-existing neurological disorder
- •Pre-existing blindness
- •Known hypersensitivity to melatonin
- •Anticoagulant use or aspirin therapy
- •Antihypertensive medication use
- •Diabetes mellitus or other endocrine disorders
- •Autoimmune disorders
Arms & Interventions
melatonin
Subjects will receive melatonin
Intervention: Melatonin
placebo
Intervention: placebo
Outcomes
Primary Outcomes
sleep
Time Frame: 3 years
Measure sleep parameters via polysomnography, actigraphy and urinary melatonin
Study Sites (1)
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