Effect of Kangaroo Mother Care on Energy Utilization in Preterm Neonates

April 22, 2026 updated by: Salwa Amin Abd Elhamid, Ain Shams University

This study aims to assess the impact of kangaroo mother care on energy utilization in preterm neonates by measuring urinary levels of xanthine, uric acid, and malondialdehyde.

It also aims to evaluate the effect of kangaroo mother care on physiological stress parameters in preterm neonates, as well as maternal emotional status

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This randomized controlled clinical trial aims to evaluate the effect of kangaroo mother care on energy utilization and oxidative stress in preterm neonates admitted to the neonatal intensive care unit (NICU) at Ain Shams University Children's Hospital, Cairo, Egypt.

Preterm neonates with gestational age between 32 and 36 weeks who meet the eligibility criteria will be enrolled and randomly assigned into two groups: an intervention group receiving kangaroo mother care and a control group receiving routine incubator care.

All enrolled neonates will receive routine incubator care until day 3 of life. On day 3, the intervention group will receive one hour of kangaroo mother care provided by the mother after feeding, while the control group will receive one hour of standard nursing care without kangaroo mother care.

Physiological parameters, including heart rate, respiratory rate, oxygen saturation, and temperature, will be monitored at baseline and every 15 minutes during the intervention period.

Urine samples will be collected from neonates 3 hours before and 3 hours after the intervention to measure biomarkers of energy utilization (xanthine and uric acid) and oxidative stress (malondialdehyde) using ELISA kits.

Maternal emotional status will be assessed using the Arabic version of the Depression Anxiety Stress Scale (DASS-21) before and after the intervention period.

The study is conducted following approval from the Research Ethics Committee of Ain Shams University, and informed consent will be obtained from parents or legal guardians prior to participation.

Study Type

Interventional

Enrollment (Estimated)

60

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
    • Salam City
      • Cairo, Salam City, Egypt, 14456
        • Ain Shams University

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

Yes

Description

Inclusion Criteria:

  • Preterm neonates (32-36 weeks)
  • Vitally stable
  • On room air or low ventilatory support

Exclusion Criteria:

  • Neonates requiring surgery
  • Intraventricular hemorrhage
  • Receiving sedatives (morphine, fentanyl, midazolam)
  • Renal impairment
  • Congenital anomalies
  • Cyanotic heart disease
  • Severe respiratory distress
  • Hemodynamic instability
  • Hypothermia
  • Parental refusal

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: study group
babies at day 3 will have kangro mother care
Behavioral: kangroo mother care

o All the preterm neonates will receive routine incubator neonatal care till day 3 of life. Then they will be subjected to the intervention according to the group; intervention group will undergo kangaroo mother care and control group without kangaroo mother care.

o The neonates in the intervention group will be given 1 hour of kangaroo mother care by their own mothers once on day 3 of life after feeding.

o The neonates in the control group will be given 1 hour of regular nursing care without kangaroo mother care once on day 3 of life after feeding.
Placebo Comparator: control group
will have routine incubator care
Behavioral: routine incubation care

o All the preterm neonates will receive routine incubator neonatal care till day 3 of life. Then they will be subjected to the intervention according to the group; intervention group will undergo kangaroo mother care and control group without kangaroo mother care.

o The neonates in the intervention group will be given 1 hour of kangaroo mother care by their own mothers once on day 3 of life after feeding.

o The neonates in the control group will be given 1 hour of regular nursing care without kangaroo mother care once on day 3 of life after feeding.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary biomarkers of energy utilization
Time Frame: 3 hours before and 3 hours after intervention on day 3 of life
Urinary xanthine and uric acid levels measured using ELISA kits.
3 hours before and 3 hours after intervention on day 3 of life
Oxidative stress marker
Time Frame: 3 hours before and 3 hours after intervention on day 3 of life
Urinary malondialdehyde level measured using ELISA kits.
3 hours before and 3 hours after intervention on day 3 of life
heart rate
Time Frame: Baseline and every 15 minutes during 1 hour intervention on day 3 of life
Heart rate measured using standard neonatal monitoring devices.
Baseline and every 15 minutes during 1 hour intervention on day 3 of life
Respiratory rate
Time Frame: Baseline and every 15 minutes during 1 hour intervention on day 3 of life
Respiratory rate measured using standard neonatal monitoring devices.
Baseline and every 15 minutes during 1 hour intervention on day 3 of life
temperature
Time Frame: Baseline and every 15 minutes during 1 hour intervention on day 3 of life
Body temperature measured using standard neonatal monitoring devices.
Baseline and every 15 minutes during 1 hour intervention on day 3 of life

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
maternal emotional status
Time Frame: : 3 hours before and 3 hours after intervention on day 3 of life
Assessed using the Arabic version of the Depression Anxiety Stress Scale (DASS-21), which consists of 21 items divided into three subscales (depression, anxiety, and stress). Each item is scored from 0 to 3, with higher scores indicating worse emotional status.
: 3 hours before and 3 hours after intervention on day 3 of life

Collaborators and Investigators

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

Sponsor

Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Morelius E, Ortenstrand A, Theodorsson E, Frostell A. Early maternal contact has an impact on preterm infants' brain systems that manage stress. Nursing children and young people. 2016; 28: 62-63.

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)

May 15, 2025

Primary Completion (Estimated)

May 15, 2026

Study Completion (Estimated)

July 15, 2026

Study Registration Dates

First Submitted

January 16, 2026

First Submitted That Met QC Criteria

April 21, 2026

First Posted (Actual)

April 23, 2026

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • medicine Ain Shams

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Impact of Kangroo on Neonates

Clinical Trials on kangroo mother care

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cyprus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe