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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 20, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 23, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 27, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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