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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01598259
Recruitment Status : Terminated (lack or enrollment, funding depletion)
First Posted : May 15, 2012
Last Update Posted : June 28, 2016
Information provided by (Responsible Party):
Michele Gottschlich, Shriners Hospitals for Children

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.

Condition or disease Intervention/treatment Phase
Burns Drug: Melatonin Other: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial to Assess Efficacy of Melatonin for Children During Burn Rehabilitation
Study Start Date : May 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns Rehabilitation
Drug Information available for: Melatonin

Arm Intervention/treatment
Experimental: melatonin
Subjects will receive melatonin
Drug: Melatonin
po 1 hour before bedtime

Placebo Comparator: placebo Other: placebo
po, 1 hour before bed

Primary Outcome Measures :
  1. sleep [ Time Frame: 3 years ]
    Measure sleep parameters via polysomnography, actigraphy and urinary melatonin

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01598259

United States, Ohio
Shriners Hospital for Children
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Shriners Hospitals for Children

Responsible Party: Michele Gottschlich, Research Scientist, Shriners Hospitals for Children Identifier: NCT01598259     History of Changes
Other Study ID Numbers: 2012-1613
First Posted: May 15, 2012    Key Record Dates
Last Update Posted: June 28, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: given low level of enrollment and hence, randomization (n=3), no plans to provide data

Additional relevant MeSH terms:
Wounds and Injuries
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants