Circadian Rhythm of Melatonin in Burns (Sleep4)

August 10, 2014 updated by: Michele Gottschlich, Shriners Hospitals for Children

Role of Circadian Rhythm of Melatonin on Sleep-related Disturbances Postburn

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

86

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Shriners Hospital for Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

pediatric burn patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
acute burns
rehab patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sleep status
Time Frame: 48hrs
actigraphy, polysomnography
48hrs

Secondary Outcome Measures

Outcome Measure
Time Frame
urinary melatonin
Time Frame: every 2 hours for 48 hrs
every 2 hours for 48 hrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shriners Hospitals for Children

Collaborators

Children's Hospital Medical Center, Cincinnati

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

May 8, 2012

First Submitted That Met QC Criteria

May 9, 2012

First Posted (Estimate)

May 10, 2012

Study Record Updates

Last Update Posted (Estimate)

August 12, 2014

Last Update Submitted That Met QC Criteria

August 10, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-07-21-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Burns

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe