Early Kangaroo Care vs. Standard Neonatal Practices: Impact on Survival and Outcomes in Preterm Infants

February 24, 2025 updated by: Nadia Elsharkawy, Jouf University

Early Kangaroo Mother Care Versus Standard Neonatal Nursing Practices: A Randomized Controlled Trial on Survival and Nursing Outcomes in Preterm Infants (<2000 g) With Mild to Moderate Respiratory Distress

This study aims to evaluate the efficacy of Early Kangaroo Mother Care (KMC) compared to standard neonatal nursing practices in improving survival rates and nursing outcomes among preterm infants weighing less than 2000 grams with mild to moderate respiratory distress. Utilizing a randomized controlled trial design, the research will be conducted in neonatal intensive care units (NICUs) across selected hospitals. Primary outcomes include infant survival rates, incidence of complications, and measures of maternal-infant bonding. Secondary outcomes involve nursing practices, caregiver satisfaction, and long-term developmental milestones. The use of validated, free assessment tools will ensure reliability and accessibility. Findings from this study are expected to inform best practices in neonatal care, potentially leading to improved health outcomes for preterm infants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Preterm birth, defined as delivery before 37 weeks of gestation, is a leading cause of neonatal morbidity and mortality worldwide. Infants weighing less than 2000 grams are particularly vulnerable to complications, including respiratory distress syndrome (RDS), which can significantly impact survival rates and long-term development. Traditional neonatal nursing practices focus on providing respiratory support, maintaining body temperature, and ensuring adequate nutrition. However, emerging evidence suggests that Kangaroo Mother Care (KMC), which emphasizes skin-to-skin contact and exclusive breastfeeding, may offer superior outcomes for preterm infants.

Kangaroo Mother Care (KMC) KMC involves continuous skin-to-skin contact between the mother and infant, promoting thermal regulation, enhancing breastfeeding, and fostering maternal-infant bonding. Studies have indicated that KMC can reduce mortality rates, lower the incidence of infections, and improve neurodevelopmental outcomes. Despite its benefits, the implementation of KMC varies across healthcare settings, and its comparative effectiveness against standard neonatal care practices warrants further investigation.

Objectives

  • To compare the survival rates of preterm infants (<2000 g) with mild to moderate respiratory distress receiving early KMC versus standard neonatal nursing practices.
  • To evaluate the impact of early KMC on nursing outcomes, including maternal-infant bonding and breastfeeding rates.
  • To assess the feasibility and acceptability of implementing early KMC in NICUs.

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Gharbia Governorate
      • Tanta, Gharbia Governorate, Egypt, 2014
        • Tanta University Hospital T

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Preterm infants born at <37 weeks of gestation.
  • Birth weight <2000 grams.
  • Diagnosed with mild to moderate respiratory distress (based on clinical criteria such as respiratory rate, oxygen saturation levels, and need for respiratory support).

Exclusion Criteria:

  • Infants with severe respiratory distress requiring mechanical ventilation.
  • Infants with congenital anomalies or other significant health issues.
  • Mothers unable or unwilling to provide KMC (e.g., due to medical conditions, lack of willingness).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early Kangaroo Mother Care Group

Early Kangaroo Mother Care Group:

  • Initiation of KMC within 24 hours of birth.
  • Continuous skin-to-skin contact for at least 8 hours per day, with gradual increase based on infant tolerance.
  • Support for exclusive breastfeeding or expressed breast milk feeding.
  • Ongoing assessment and support from trained neonatal nurses and lactation consultants.
Other: Early Kangaroo Mother Care
  • Initiation of KMC within 24 hours of birth.
  • Continuous skin-to-skin contact for at least 8 hours per day, with gradual increase based on infant tolerance.
  • Support for exclusive breastfeeding or expressed breast milk feeding.
  • Ongoing assessment and support from trained neonatal nurses and lactation consultants.
No Intervention: Control Group

Control Group:

  • Standard neonatal nursing practices, including incubator care, intermittent holding, and feeding as per clinical guidelines.
  • Respiratory support as needed based on the severity of respiratory distress.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival Rates
Time Frame: Up to 24 weeks

Survival Rates will be the proportion of preterm infants who survive following the implementation of KMC, a practice emphasizing continuous skin-to-skin contact and exclusive breastfeeding.

For infants weighing less than 2000 grams, KMC has been associated with reduced mortality, particularly in low-resource settings where conventional neonatal care may be limited. By promoting physiological stability, enhancing maternal bonding, and reducing the risk of severe complications like infections and hypothermia, KMC offers a cost-effective and impactful approach to improving survival outcomes in this vulnerable population.
Up to 24 weeks
Incidence of Complications
Time Frame: Up to 24 weeks
Incidence of Complications Including infections, intraventricular hemorrhage, and necrotizing enterocolitis.
Up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jouf University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

June 30, 2024

Study Completion (Actual)

January 1, 2025

Study Registration Dates

First Submitted

November 20, 2024

First Submitted That Met QC Criteria

November 23, 2024

First Posted (Actual)

November 27, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 24, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 547-10-2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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