Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Shriners Hospitals for Children
Information provided by (Responsible Party):
Michele Gottschlich, Shriners Hospitals for Children Identifier:
First received: May 8, 2012
Last updated: February 16, 2015
Last verified: February 2015

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
Official Title: Randomized Controlled Trial to Assess Efficacy of Melatonin for Children During Burn Rehabilitation

Resource links provided by NLM:

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: May 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (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


Ages Eligible for Study:   5 Years to 22 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01598259

Contact: Michele Gottschlich, PhD 6513-872-6298

United States, Ohio
Shriners Hospital for Children Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Michele Gottschlich, PhD    513-872-6298   
Sponsors and Collaborators
Shriners Hospitals for Children
  More Information

No publications provided

Responsible Party: Michele Gottschlich, Research Scientist, Shriners Hospitals for Children Identifier: NCT01598259     History of Changes
Other Study ID Numbers: 2012-1613
Study First Received: May 8, 2012
Last Updated: February 16, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Central Nervous System Agents
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses processed this record on February 27, 2015