Status:
WITHDRAWN
Improving Sleep in the Pediatric Intensive Care Unit
Lead Sponsor:
University of Rochester
Conditions:
Critically Ill
Eligibility:
All Genders
1-15 years
Phase:
NA
Brief Summary
Sleep is disrupted in the PICU. This disruption has been reported in studies that have used: (a) observation of sleep-wake cycles (b) self-reports by children themselves , and (c) objective measures (...
Detailed Description
While often life saving, the need for admission to the pediatric intensive care unit (PICU) places children in a profoundly artificial environment that has the potential to alter the biological proces...
Eligibility Criteria
Inclusion
- Parents or primary caregivers ages 18 years or older, who can read and speak English and their critically ill children who meet the following criteria will be eligible for participation (a) ages 1-15 years, (b) anticipated survival, (c) no severe handicapping (neurological) conditions, (d) not a prior transplant patient, (e) no active oncology or metabolic process (other than diabetes), (f) not diagnosed with a traumatic brain injury and (a) between 1 and 15 years of age, (b) expected length of stay \>2days, (c) expected to live, and (d) parents that can read and write English
Exclusion
- diagnosis of cancer, a previous transplant patient, diagnosis of a metabolic disorder (except for diabetes), neurological conditions that would affect sleep wake cycles, a traumatic brain injury patient, evidence of abuse. These conditions are known to affect sleep patterns and/or immune system and (a) not meeting inclusion criteria, (b) anticipated death of the child, (c) parents/primary caregiver make a personal choice to withdraw themselves and their child from the study, (d) the child has evidence of abuse.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00178321
Start Date
September 1 2005
End Date
August 1 2006
Last Update
April 30 2015
Active Locations (1)
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1
University of Rochester
Rochester, New York, United States, 14642