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Circadian Rhythm of Melatonin in Burns (Sleep4)

This study has been completed.
Children's Hospital Medical Center, Cincinnati
Information provided by (Responsible Party):
Michele Gottschlich, Shriners Hospitals for Children Identifier:
First received: May 8, 2012
Last updated: August 10, 2014
Last verified: August 2014
Evaluate markers and postulated effectors of the endogenous circadian pacemaker in children admitted to the burn intensive care unit.


Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Role of Circadian Rhythm of Melatonin on Sleep-related Disturbances Postburn

Resource links provided by NLM:

Further study details as provided by Shriners Hospitals for Children:

Primary Outcome Measures:
  • sleep status [ Time Frame: 48hrs ]
    actigraphy, polysomnography

Secondary Outcome Measures:
  • urinary melatonin [ Time Frame: every 2 hours for 48 hrs ]

Enrollment: 86
Study Start Date: April 2009
Study Completion Date: August 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
acute burns
rehab patients


Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
pediatric burn patients

Inclusion Criteria:

  • 5-18 years old

Exclusion Criteria:

  • anoxic brain injury
  • preexisting neurological disorder
  • pre-existing sleep disorder
  • no informed consent or HIPAA release
  Contacts and Locations
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Please refer to this study by its identifier: NCT01596101

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

Responsible Party: Michele Gottschlich, Director, Nutrition Services, Shriners Hospitals for Children Identifier: NCT01596101     History of Changes
Other Study ID Numbers: 08-07-21-03
Study First Received: May 8, 2012
Last Updated: August 10, 2014

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants processed this record on May 23, 2017