Ignite Creation Date:
2024-05-06 @ 7:07 AM
Last Modification Date:
2024-10-26 @ 11:45 AM
Study NCT ID:
NCT02473055
Status:
COMPLETED
Last Update Posted:
2015-06-18
First Post:
2015-06-10
Brief Title:
Kangaroo Care and Premature Infant Sleep
Sponsor:
Case Western Reserve University
Organization:
Case Western Reserve University
Study Overview
Official Title:
A Randomized Controlled Trial of Kangaroo Care Skin-to-Skin Effects on Sleep in Premature Infants
Status:
COMPLETED
Status Verified Date:
2015-06
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:
90 preterm infants were randomly assigned to kangaroo care skin-to-skin chest-to-chest group n50 or control remained in incubator prone n40 for a pretest period of 2- 3 hours then fed then KC group was placed in KC and control group remained in incubator for a 2-3 hr test period EEG measures of sleep HR and RR were taken
Detailed Description:
The neonatal intensive care unit NICU environment is not conducive to sleep and infant sleep in incubators is fragmented Sleep contributes to brain maturation so interventions to foster sleep are needed During Kangaroo Care KC behavioral indicators of Quiet Sleep have been observed but not confirmed by objective electroencephalographic EEG analysisThe purpose was to determine the effects of Kangaroo Care KC on EEG-based sleep using Nihon Koden polysomnography and cardiorespiratory patterns by comparing KC sleep to incubator sleep A randomized controlled study with 90 preterms KC 50 control 40 in which KC infants received 2-3 hours of KC between feeds after a comparable pretest period in an incubator and control infants remained in an incubator during the 2-3 hour pretest and test periods In the incubator infants were inclined prone and nested in KC infants were inclined prone and chest-to-chest underneath a blanket The medically stable preterm infants were a mean 32 weeks postmenstrual age
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