Improving Sleep in the Pediatric Intensive Care Unit

Withdrawn before enrolling · Not applicable

Conditions studied: Critically Ill

In brief

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 (e.g., electroencephalograph( EEG). Noise and light levels have been correlated with profound sleep disruption in the PICU . Sleep disruption is known to have a profound impact on the overall health of a child, both from a physiological and a psychological standpoint . In addition, sleep disruption has been shown to change cortisol levels, cause impaired immune responses and impair cognitive function in both children and adults . Disruption in sleep also is known to impair healing through these many complex connections with other homeostatic processes in the human body. What is the effect of wearing earplugs in critically ill children admitted to the PICU on: 1. Sleep states 2. Physiological stability (e.g. melatonin, cortisol and immune status) 3. Sleep habits after discharge from the PICU (on the general pediatric unit, 2 weeks and 2 months after discharge), and 4. Child behavior at 2 weeks and 2 months after discharge from the PICU by parent report on the Child Behavior Checklist (CBCL).

Key facts

Study ID

NCT00178321

Run by

University of Rochester

People needed

0

Starts

2005-09-01

Expected to finish

2006-08-01

Last updated by the study team

2015-04-30

Who can join

Age: 1 and older, up to 15. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Rochester — Rochester, New York, United States

Full record on ClinicalTrials.gov

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