Clinical trial NCT02473055: Kangaroo Care and Premature Infant Sleep
Official title: A Randomized Controlled Trial of Kangaroo Care (Skin-to-Skin) Effects on Sleep in Premature Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Birth of Newborn
Keywords: kangaroo care
sleep
heart rate
respiratory rate
preterm infant
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
First posted: 2015-06-16
Enrollment: 90
Sex: ALL
Minimum age (years): 7
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: EEG-based sleep
timeFrame: 2-3 hours
Secondary outcomes:
measure: Heart rates during pretest
timeFrame: 2-3 hours of pretest
measure: Respiratory rate during pretest
timeFrame: 2-3 hours pretest
measure: Heart rates during test
timeFrame: 2-3 hours of test
measure: Respiratory rate during test period
timeFrame: 2-3 hours test period
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: UH hospitals
state: Ohio
Study officials:
affiliation: Case Western Reserve University Frances Payne Bolton School of Nursing
name: Susan Ludington
role: PRINCIPAL_INVESTIGATOR
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