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Improving Sleep in the Pediatric Intensive Care Unit

Primary Purpose

Critically Ill

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
earplugs
Sponsored by
University of Rochester
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Critically Ill focused on measuring Sleep, Criticall Ill, Children, Earplugs

Eligibility Criteria

1 Year - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Criteria: 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.

Sites / Locations

  • University of Rochester

Outcomes

Primary Outcome Measures

To pilot test the changes in sleep patterns with the use of earplugs in the PICU

Secondary Outcome Measures

To see if there are neurobehavioral differences in children who use the earplugs in the PICU vs, those who do not

Full Information

First Posted
September 12, 2005
Last Updated
April 29, 2015
Sponsor
University of Rochester
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1. Study Identification

Unique Protocol Identification Number
NCT00178321
Brief Title
Improving Sleep in the Pediatric Intensive Care Unit
Official Title
Improving Sleep and Outcomes in Critically Ill Children
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Withdrawn
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Rochester

4. Oversight

5. Study Description

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 (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: Sleep states Physiological stability (e.g. melatonin, cortisol and immune status) Sleep habits after discharge from the PICU (on the general pediatric unit, 2 weeks and 2 months after discharge), and Child behavior at 2 weeks and 2 months after discharge from the PICU by parent report on the Child Behavior Checklist (CBCL).
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 processes that defend homeostasis. All living organisms have biological rhythms that serve as their basic organizing feature. These rhythms vary widely, ranging from seconds (e.g., heartbeat) to weeks (menstrual cycle). Biological rhythms that have a 24-hour cycle are termed circadian rhythms. Of the many circadian rhythms, the sleep-wake cycle is the most evident [2]. Other biological processes that have a circadian rhythm include growth hormone, melatonin, and cortisol secretion . Sleep is disrupted in the PICU. This disruption has been reported in studies that have used: (a) observation of sleep-wake cycles [6, 7]; (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. There is a dearth of research on improving sleep and reversing the negative effects of sleep disruption on homeostasis in critically ill children RQ1: What is the effect of wearing earplugs in critically ill children admitted to the PICU on: Sleep states Physiological stability (e.g. melatonin, cortisol and immune status) Sleep habits after discharge from the PICU (on the general pediatric unit, 2 weeks and 2 months after discharge), and Child behavior at 2 weeks and 2 months after discharge from the PICU by parent report on the Child Behavior Checklist (CBCL).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critically Ill
Keywords
Sleep, Criticall Ill, Children, Earplugs

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
earplugs
Primary Outcome Measure Information:
Title
To pilot test the changes in sleep patterns with the use of earplugs in the PICU
Secondary Outcome Measure Information:
Title
To see if there are neurobehavioral differences in children who use the earplugs in the PICU vs, those who do not

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret-Ann Carno, PhD, RN
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Heidi V. Connolly, MD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

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Improving Sleep in the Pediatric Intensive Care Unit

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