Circadian Rhythm of Melatonin in Burns (Sleep4)

This study is ongoing, but not recruiting participants.
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: November 29, 2013
Last verified: November 2013

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 ] [ Designated as safety issue: No ]
    actigraphy, polysomnography

Secondary Outcome Measures:
  • urinary melatonin [ Time Frame: every 2 hours for 48 hrs ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: April 2009
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
Genders Eligible for Study:   Both
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
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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

No publications provided

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: November 29, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Wounds and Injuries
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Molecular Mechanisms of Pharmacological Action
Protective Agents processed this record on July 29, 2014