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

This study has been terminated.
(lack or enrollment, funding depletion)
Information provided by (Responsible Party):
Michele Gottschlich, Shriners Hospitals for Children Identifier:
First received: May 8, 2012
Last updated: June 27, 2016
Last verified: June 2016
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
Burns Drug: Melatonin Other: placebo Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Michele Gottschlich, Shriners Hospitals for Children:

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

Enrollment: 10
Study Start Date: May 2014
Study Completion Date: June 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: melatonin
Subjects will receive melatonin
Drug: Melatonin
po 1 hour before bedtime
Placebo Comparator: placebo Other: placebo
po, 1 hour before bed


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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01598259

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

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: June 27, 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 processed this record on August 22, 2017