Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00178321
Status:
WITHDRAWN
Last Update Posted:
2015-04-30
First Post:
2005-09-12
Brief Title:
Improving Sleep in the Pediatric Intensive Care Unit
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
Improving Sleep and Outcomes in Critically Ill Children
Status:
WITHDRAWN
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg 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 eg 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
1 Sleep states
2 Physiological stability eg 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
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 eg 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 eg 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
1 Sleep states
2 Physiological stability eg 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
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 eg 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
1 Sleep states
2 Physiological stability eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None