Circadian Rhythm of Melatonin in Burns (Sleep4)
This study is currently recruiting participants.
Verified December 2012 by Shriners Hospitals for Children
Sponsor:
Shriners Hospitals for Children
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
| Tracking Information | |||||||||
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| First Received Date ICMJE | May 8, 2012 | ||||||||
| Last Updated Date | December 12, 2012 | ||||||||
| Start Date ICMJE | April 2009 | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
sleep status [ Time Frame: 48hrs ] [ Designated as safety issue: No ] actigraphy, polysomnography |
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| Original Primary Outcome Measures ICMJE |
actigraphy [ Time Frame: 48hrs ] [ Designated as safety issue: No ] | ||||||||
| Change History | Complete list of historical versions of study NCT01596101 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
urinary melatonin [ Time Frame: every 2 hours for 48 hrs ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Circadian Rhythm of Melatonin in Burns | ||||||||
| Official Title ICMJE | Role of Circadian Rhythm of Melatonin on Sleep-related Disturbances Postburn | ||||||||
| Brief Summary | Evaluate markers and postulated effectors of the endogenous circadian pacemaker in children admitted to the burn intensive care unit. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | pediatric burn patients |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 30 | ||||||||
| Completion Date | Not Provided | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 5 Years to 18 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01596101 | ||||||||
| Other Study ID Numbers ICMJE | 08-07-21-03 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Michele Gottschlich, Shriners Hospitals for Children | ||||||||
| Study Sponsor ICMJE | Shriners Hospitals for Children | ||||||||
| Collaborators ICMJE | Children's Hospital Medical Center, Cincinnati | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | Shriners Hospitals for Children | ||||||||
| Verification Date | December 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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