Kangaroo Care and Premature Infant Sleep

June 16, 2015 updated by: Susan Ludington, Case Western Reserve University

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

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. .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • UH hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 week to 8 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Other: Kangaroo Care
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.
Other Names:
  • skin-to-skin contact
No Intervention: control
control infants remained prone in an incubator wearing only diaper

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EEG-based sleep
Time Frame: 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
2-3 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Case Western Reserve University

Investigators

  • Principal Investigator: Susan Ludington, Case Western Reserve University Frances Payne Bolton School of Nursing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

June 10, 2015

First Submitted That Met QC Criteria

June 12, 2015

First Posted (Estimate)

June 16, 2015

Study Record Updates

Last Update Posted (Estimate)

June 18, 2015

Last Update Submitted That Met QC Criteria

June 16, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KangarooCareEEG

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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