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Circadian Rhythm of Melatonin in Burns (Sleep4)

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.
ClinicalTrials.gov Identifier: NCT01596101
Recruitment Status : Completed
First Posted : May 10, 2012
Last Update Posted : August 12, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Evaluate markers and postulated effectors of the endogenous circadian pacemaker in children admitted to the burn intensive care unit.

Condition or disease
Sleep Burns

Study Design

Study Type : Observational
Actual Enrollment : 86 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Role of Circadian Rhythm of Melatonin on Sleep-related Disturbances Postburn
Study Start Date : April 2009
Primary Completion Date : November 2013
Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns
Drug Information available for: Melatonin
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
acute burns
rehab patients


Outcome Measures

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


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

Eligibility Criteria

Information from the National Library of Medicine

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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
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT01596101


Locations
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
ClinicalTrials.gov Identifier: NCT01596101     History of Changes
Other Study ID Numbers: 08-07-21-03
First Posted: May 10, 2012    Key Record Dates
Last Update Posted: August 12, 2014
Last Verified: August 2014

Additional relevant MeSH terms:
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants