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Kangaroo Care and Premature Infant Sleep

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02473055
Enrollment
90
Registered
2015-06-16
Start date
2003-01-31
Completion date
2015-05-31
Last updated
2015-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Birth of Newborn

Keywords

kangaroo care, sleep, heart rate, respiratory rate, preterm infant

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.

Interventions

OTHERKangaroo 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.

Sponsors

Case Western Reserve University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
7 Days to 37 Weeks
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
EEG-based sleep2-3 hoursInfants attached to EEG machine and Respiratory impedance plethysmography bands prior to beginning of pretest period and remainded on EEG until end of study

Secondary

MeasureTime frameDescription
Heart rates during pretest2-3 hours of pretestHeart Rate was detected by Nihon Koden polysomnograph
Respiratory rate during pretest2-3 hours pretestImpedance plethysmography belts attached to Nihon Koden polysomnograph machine
Heart rates during test2-3 hours of testHeart rate was detected by Nihon Koden polysomnograph
Respiratory rate during test period2-3 hours test periodImpedance plethysmography belts attached to Nihon Koden polysomnograph machine

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026