Kangaroo Care and Premature Infant Sleep

Not Applicable

Completed

• Conditions: Premature Birth of Newborn
• Interventions: Other: Kangaroo Care

• Registration Number: NCT02473055
• Lead Sponsor: Case Western Reserve University

Brief Summary

90 preterm infants were randomly assigned to kangaroo care (skin-to-=skin, chest-to-chest) group (n=50) or control (remained in incubator, prone (n=40) 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) analysis.The 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 Timeline

• Study Start: 2003-01
• Primary Completion: 2008-06
• Study Completion: 2015-05
• Status Verified: 2015-06
• Study First Submitted: 2015-06-10
• Study First Submitted QC: 2015-06-12
• Study First Posted: 2015-06-16
• Last Update Submitted: 2015-06-16
• Last Update Posted: 2015-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Subjects whose five-minute APGARS were greater than 6, gestational age was 28 or more weeks at birth, and whose testing weight was greater than 1000 grams were included.

Exclusion Criteria

• Infants with encephalopathy, intraventricular hemorrhage greater than grade II, white matter lucencies on cranial ultrasound, seizures, meningitis, or congenital brain malformations were excluded

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Kangaroo care	Kangaroo Care	kangaroo Care was skin-to-skin, chest-to-chest placement of preterm infant wearing only a diaper placed up against mother's chest and covered in one receiving blanket folded into fourth

Primary Outcome Measures

Name	Time	Method
EEG-based sleep	2-3 hours	Infants attached to EEG machine and Respiratory impedance plethysmography bands prior to beginning of pretest period and remainded on EEG until end of study

Secondary Outcome Measures

Name	Time	Method
Heart rates during pretest	2-3 hours of pretest	Heart Rate was detected by Nihon Koden polysomnograph
Respiratory rate during pretest	2-3 hours pretest	Impedance plethysmography belts attached to Nihon Koden polysomnograph machine
Respiratory rate during test period	2-3 hours test period	Impedance plethysmography belts attached to Nihon Koden polysomnograph machine
Heart rates during test	2-3 hours of test	Heart rate was detected by Nihon Koden polysomnograph

Trial Locations

Locations (1)

UH hospitals; 🇺🇸 Cleveland, Ohio, United States