Improving Sleep in the Pediatric Intensive Care Unit

NCT00178321 | Withdrawn

• 1 other identifier: 10055
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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:

1. 1.Sleep states
2. 2.Physiological stability (e.g. melatonin, cortisol and immune status)
3. 3.Sleep habits after discharge from the PICU (on the general pediatric unit, 2 weeks and 2 months after discharge), and
4. 4.Child behavior at 2 weeks and 2 months after discharge from the PICU by parent report on the Child Behavior Checklist (CBCL).

Conditions

Critically Ill

Keywords

Sleep; Criticall Ill; Children; Earplugs

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

earplugs DEVICE

Eligibility Criteria

• Age: 1 Year - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Critical Illness

Interventions

Ear Protective Devices

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Personal Protective Equipment; Protective Devices; Equipment and Supplies; Protective Clothing; Clothing; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Margaret-Ann Carno, PhD, RN

  University of Rochester

  PRINCIPAL INVESTIGATOR

• Heidi V. Connolly, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 15, 2005
• Study Start: September 1, 2005
• Study Completion: August 1, 2006
• Last Updated: April 30, 2015

Record last verified: 2015-04

Locations

US (1)