Skip to main content
OpenTrials
Completed

NCT Number: NCT02473055

Kangaroo Care and Premature Infant Sleep

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. .

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Premature Birth of Newborn Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

7 day–37 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UH hospitals

Cleveland, Ohio, 44106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kangaroo Care

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Heart rates during pretest

    Time frame: 2-3 hours of pretest

    Heart Rate was detected by Nihon Koden polysomnograph

  2. Respiratory rate during pretest

    Time frame: 2-3 hours pretest

    Impedance plethysmography belts attached to Nihon Koden polysomnograph machine

  3. Heart rates during test

    Time frame: 2-3 hours of test

    Heart rate was detected by Nihon Koden polysomnograph

  4. Respiratory rate during test period

    Time frame: 2-3 hours test period

    Impedance plethysmography belts attached to Nihon Koden polysomnograph machine

Sponsors and collaborators

Lead sponsor

Case Western Reserve University

Other

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2008
Study completion
2015
First posted
Jun 16, 2015
Registry last updated
Jun 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.