Clinical Trials Logo

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. .


Clinical Trial 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 Design

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


Related Conditions & MeSH terms


NCT number NCT02473055
Study type Interventional
Source Case Western Reserve University
Contact
Status Completed
Phase N/A
Start date January 2003
Completion date May 2015

See also
  Status Clinical Trial Phase
Active, not recruiting NCT02452580 - The Norwegian Family Centered Care Study
Completed NCT02502916 - Enteral Feeding and Early Gut Colonization of Preterm Infants N/A
Completed NCT01748214 - Premature Infant Exposure to Noise Generated by Respiratory Support N/A
Terminated NCT02840825 - Biochip for HCMV Detection in Breast Milk
Recruiting NCT02306317 - The Adding Value of Parents to Nursing Care in the Control of FiO2 N/A
Completed NCT01354028 - Effects of Massage Therapy to Induce Sleep in Preterm Infants N/A
Completed NCT01881256 - The BabyGrow Longitudinal Study of Nutrition and Growth in Preterm Infants N/A
Completed NCT03001479 - Noninferiority Trial of Liquid Human Milk Fortifier (HMF) Hydrolyzed Protein Versus Liquid HMF With Supplemental Liquid Protein N/A
Completed NCT02788786 - Feasibility and Acceptability of Use of Daily Oral Rinse in Pregnant Women in Rural Nepal Phase 2
Completed NCT01678638 - Timing of Inguinal Hernia Repair in Premature Infants N/A
Recruiting NCT02623400 - The Effect of Perinatal Stress on the Development of Preterm Infants
Completed NCT02523222 - Prophylactic Dextrose Gel for Newborns at High-risk for Hypoglycemia N/A
Active, not recruiting NCT02508571 - Direct Swallowing Training and Oral Sensorimotor Stimulation in Preterm Infants N/A
Completed NCT02478684 - Delayed Cord Clamping in Preterm Neonates N/A
Completed NCT02477423 - A Randomized Controlled Trial Investigating if Antibiotic Use in the First 48 Hours of Life Adversely Impacts the Preterm Infant Microbiome N/A
Terminated NCT02040909 - Optimizing Propofol Dosing for (Preterm) Newborn Infants That Need Endotracheal Intubation Phase 1
Completed NCT00722943 - Neuroendocrine Mechanisms of Developmental Massage Therapy (DMT) in Preterm Infants: Clinical Study N/A
Active, not recruiting NCT02832011 - How Effect Olive Oil and Eoprotin on Immunological Parameters and Growth N/A
Completed NCT02643472 - GPS (Giving Parents Support): Parent Navigation After NICU Discharge N/A
Terminated NCT01759134 - Comparison of Post-Discharge Growth of Premature Infants Using Two Different Formulas Phase 4