NCT01596101

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 10, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

August 12, 2014

Status Verified

August 1, 2014

Enrollment Period

4.6 years

First QC Date

May 8, 2012

Last Update Submit

August 10, 2014

Conditions

SleepBurns

Outcome Measures

Primary Outcomes (1)

  • sleep status

    actigraphy, polysomnography

    48hrs

Secondary Outcomes (1)

  • urinary melatonin

    every 2 hours for 48 hrs

Study Arms (2)

acute burns

rehab patients

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

pediatric burn patients

You may qualify if:

  • years old

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shriners Hospital for Children

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Nutrition Services

Study Record Dates

First Submitted

May 8, 2012

First Posted

May 10, 2012

Study Start

April 1, 2009

Primary Completion

November 1, 2013

Study Completion

August 1, 2014

Last Updated

August 12, 2014

Record last verified: 2014-08

Locations

US(1)