Kangaroo Care and Premature Infant Sleep

Premature Birth of Newborn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02473055
• Other study ID #: KangarooCareEEG
• Status: Completed
• Phase: N/A
• First received: June 10, 2015
• Last updated: June 16, 2015
• Start date: January 2003
• Est. completion date: May 2015

Study information

• Verified date: June 2015
• Source: Case Western Reserve University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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. .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 2015
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 37 Weeks

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Premature Birth
• Premature Birth of Newborn

Intervention

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.

Locations

Country	Name	City	State
United States	UH hospitals	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Western Reserve University

Country where clinical trial is conducted

United States, 

References & Publications (31)

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* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Heart rates during pretest	Heart Rate was detected by Nihon Koden polysomnograph	2-3 hours of pretest	No
Secondary	Respiratory rate during pretest	Impedance plethysmography belts attached to Nihon Koden polysomnograph machine	2-3 hours pretest	No
Secondary	Heart rates during test	Heart rate was detected by Nihon Koden polysomnograph	2-3 hours of test	No
Secondary	Respiratory rate during test period	Impedance plethysmography belts attached to Nihon Koden polysomnograph machine	2-3 hours test period	No