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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

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

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

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 (Estimated)

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.
60

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 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

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

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

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: 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

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
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

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

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.
May 15, 2025

Primary Completion (Estimated)

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.
May 15, 2026

Study Completion (Estimated)

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.
July 15, 2026

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).
January 16, 2026

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.
April 21, 2026

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.
April 23, 2026

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.
April 27, 2026

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.
April 22, 2026

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.
April 1, 2026

More Information

Terms related to this study

Keywords

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.
  • 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.

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