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NCT01596101 Clinical Trial

Circadian Rhythm of Melatonin in Burns

Sleep Clinical Trial

— Sleep4  

Official title:
Role of Circadian Rhythm of Melatonin on Sleep-related Disturbances Postburn

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01596101
Other study ID # 08-07-21-03
Secondary ID
Status Completed
Phase N/A
First received May 8, 2012
Last updated August 10, 2014
Start date April 2009
Est. completion date August 2014

Study information
Verified date August 2014
Source Shriners Hospitals for Children
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 86
Est. completion date August 2014
Est. primary completion date November 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 5 Years to 18 Years
Eligibility Inclusion Criteria:

- 5-18 years old

Exclusion Criteria:

- anoxic brain injury

- preexisting neurological disorder

- pre-existing sleep disorder

- no informed consent or HIPAA release

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Shriners Hospital for Children Cincinnati Ohio

Sponsors (2)
Lead Sponsor Collaborator
Shriners Hospitals for Children Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary sleep status actigraphy, polysomnography 48hrs No
Secondary urinary melatonin every 2 hours for 48 hrs No
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