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Circadian Rhythm of Melatonin in Burns (Sleep4)

This study is currently recruiting participants.
Verified December 2012 by Shriners Hospitals for Children
Sponsor:
Collaborator:
Children's Hospital Medical Center, Cincinnati
Information provided by (Responsible Party):
Michele Gottschlich, Shriners Hospitals for Children
ClinicalTrials.gov Identifier:
NCT01596101
First received: May 8, 2012
Last updated: December 12, 2012
Last verified: December 2012
History of Changes
  Purpose

Evaluate markers and postulated effectors of the endogenous circadian pacemaker in children admitted to the burn intensive care unit.


Condition
Sleep
Burns

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:

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

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
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
acute burns
rehab patients

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01596101

Contacts
Contact: Michele M Gottschlich, PhD, RD, CNSD 513-872-6298 mgottschlich@shrinenet.org
Contact: Theresa Mayes, BS, RD 513-872-6043 tmayes@shrinenet.org

Locations
United States, Ohio
Shriners Hospital for Children Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Michele M Gottschlich, PhD     513-872-6298     mgottschlich@shrinenet.org    
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
ClinicalTrials.gov Identifier: NCT01596101     History of Changes
Other Study ID Numbers: 08-07-21-03
Study First Received: May 8, 2012
Last Updated: December 12, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Burns
Wounds and Injuries
Melatonin
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on May 16, 2013