Kangaroo Care and Premature Infant Sleep

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Controlled Trial of Kangaroo Care (Skin-to-Skin) Effects on Sleep in Premature Infants

Conditions
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Premature Birth of Newborn

Intervention / Treatment
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* Other: Kangaroo Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Days
Maximum Age: 37 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kangaroo care<br>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 | Other: Kangaroo Care<br>* skin-to-skin, chest-to-chest placement of diaper clad preterm infant up against his mother's chest and covered by a receiving blanket folded into fourths for 2-3 hours from one feeding to the next.<br>* Other names: skin-to-skin contact;|
| No Intervention: control<br>control infants remained prone in an incubator wearing only diaper | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EEG-based sleep | Infants attached to EEG machine and Respiratory impedance plethysmography bands prior to beginning of pretest period and remainded on EEG until end of study | 2-3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rates during pretest | Heart Rate was detected by Nihon Koden polysomnograph | 2-3 hours of pretest | 
| Respiratory rate during pretest | Impedance plethysmography belts attached to Nihon Koden polysomnograph machine | 2-3 hours pretest | 
| Heart rates during test | Heart rate was detected by Nihon Koden polysomnograph | 2-3 hours of test | 
| Respiratory rate during test period | Impedance plethysmography belts attached to Nihon Koden polysomnograph machine | 2-3 hours test period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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kangaroo care, sleep, heart rate, respiratory rate, preterm infant