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CompletedNCT01596101Sleep4Updated Aug 12, 2014

Circadian Rhythm of Melatonin in Burns

An observational study in Sleep and Burns, sponsored by Shriners Hospitals for Children. Completed at 1 site in United States. Open to participants aged 5 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-08-12.

Sponsored by Shriners Hospitals for Children · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
86
Ages
5 Years to 18 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Sleep
  • Burns

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03

In context

Burns

719 studies on the registry are indexed under Burns; 145 are open to participants now.

This study's enrollment of 86 is above the median of 55 across 135 observational studies indexed under Burns.

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Lead sponsor

Shriners Hospitals for Children is the lead sponsor of 56 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

pediatric burn patients

Inclusion criteria

  • 5-18 years old

Exclusion criteria

Exclusion Criteria:

  • anoxic brain injury
  • preexisting neurological disorder
  • pre-existing sleep disorder
  • no informed consent or HIPAA release
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
86 participants (actual)
Patient registry
No

Groups and cohorts

  • acute burns
  • rehab patients
06

What researchers measure

Primary outcomes

  1. sleep status

    actigraphy, polysomnography

    Time frame: 48hrs

Secondary outcomes

  1. urinary melatonin

    Time frame: every 2 hours for 48 hrs

07

Study locations

1 site
  • Shriners Hospital for Children
    Cincinnati, Ohio 45229, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01596101
Lead sponsor
Shriners Hospitals for Children
Collaborators
Children's Hospital Medical Center, Cincinnati
Responsible party
Michele Gottschlich (Director, Nutrition Services, Shriners Hospitals for Children) — Principal investigator
First posted
May 10, 2012
Start date
Apr 2009
Primary completion
Nov 2013
Completion
Aug 2014
Last update
Aug 12, 2014

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.

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