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Randomized Controlled Trial to Assess Efficacy of Melatonin for Children During Burn Rehabilitation (Sleep6)

This study is not yet open for participant recruitment.
Verified December 2012 by Shriners Hospitals for Children
Sponsor:
Information provided by (Responsible Party):
Michele Gottschlich, Shriners Hospitals for Children
ClinicalTrials.gov Identifier:
NCT01598259
First received: May 8, 2012
Last updated: December 14, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Pediatric Burns
 Drug: Melatonin
Other: placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Burns Rehabilitation
Drug Information available for: Melatonin
U.S. FDA Resources

Further study details as provided by Shriners Hospitals for Children:

Primary Outcome Measures:
  • sleep [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Measure sleep parameters via polysomnography, actigraphy and urinary melatonin


Estimated Enrollment: 110
Study Start Date: January 2013
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: melatonin
Subjects will receive melatonin
 Drug: Melatonin
po 1 hour before bedtme
Placebo Comparator: placebo Other: placebo
po, 1 hour before bed

  Eligibility

Ages Eligible for Study:   5 Years to 22 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • Schizophrenia
  • Inability to access internet
  • Intellectual disability or inability to follow directions
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01598259

Contacts
Contact: Michele Gottschlih, PhD 6513-872-6298 mgottschlich@shrinenet.org

Locations
United States, Ohio
Shriners Hospital for Children Not yet recruiting
Cincinnati, Ohio, United States, 45229
Contact: Michele Gottschlich, PhD     513-872-6298     mgottschlich@shrinenet.org    
Sponsors and Collaborators
Shriners Hospitals for Children
  More Information

No publications provided

Responsible Party: Michele Gottschlich, Director, Nutrition Services, Shriners Hospitals for Children
ClinicalTrials.gov Identifier: NCT01598259     History of Changes
Other Study ID Numbers: 2012-1613
Study First Received: May 8, 2012
Last Updated: December 14, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Burns
Wounds and Injuries
Melatonin
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on May 19, 2013