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OpenTrials
Completed

NCT Number: NCT07259486

Comparison of Outcomes of Early Kangaroo Mother Care and Standard Method Care in Healthy Low Birth Weight Preterm Neonates at a Tertiary Care Hospital

The goal of this clinical trial is to learn whether early initiation of kangaroo mother care (KMC) can improve clinical outcomes in healthy low birth weight preterm neonates (gestational age 30-37 weeks, birth weight <2000 g). The study will be conducted among preterm infants admitted to the neonatal unit of Services Hospital Lahore.

The main questions it aims to answer are:

* Does early kangaroo mother care initiated within the first 24 hours of birth improve neonatal outcomes compared with standard neonatal care? * Does early initiation of kangaroo mother care improve thermal stability, breastfeeding outcomes, and overall clinical recovery in low birth weight preterm infants?

Researchers will compare early kangaroo mother care with standard neonatal care to see if early initiation of skin-to-skin contact and breastfeeding support improves neonatal outcomes.

Participants will:

* Be randomly assigned to receive either early kangaroo mother care or standard neonatal care. * Infants in the intervention group will receive early skin-to-skin contact with the mother or caregiver along with breastfeeding support according to hospital protocols. * Infants in the control group will receive standard neonatal care practices provided in the neonatal unit.

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Key information

Age range

1 hour–24 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Hospital and Medical Centre

Lahore, Punjab Province, 56300, Pakistan

About this study

Preterm birth remains the leading cause of mortality among children under five years of age worldwide. Each year approximately 15 million infants are born prematurely, accounting for more than one in ten births globally. Complications related to prematurity contribute substantially to neonatal mortality and long-term morbidity, particularly in low- and middle-income countries. Pakistan has one of the highest reported rates of preterm birth globally, highlighting the urgent need for effective, low-cost neonatal care strategies.

Low birth weight (LBW) preterm infants are particularly vulnerable to hypothermia, infection, feeding difficulties, and other complications due to physiologic immaturity. Conventional neonatal care for these infants often relies on incubators, radiant warmers, and specialized monitoring, which may be resource-intensive and difficult to sustain in high-volume public hospitals in low-resource settings.

Kangaroo Mother Care (KMC) is a cost-effective and evidence-based intervention designed to improve outcomes for preterm and LBW infants. The intervention consists primarily of continuous or intermittent skin-to-skin contact between the caregiver and infant, promotion of exclusive breastfeeding or breast-milk feeding, early discharge when clinically appropriate, and structured follow-up. Skin-to-skin contact helps maintain thermal stability, enhances breastfeeding success, and strengthens maternal-infant bonding. Previous studies and systematic reviews have demonstrated that KMC can reduce neonatal mortality, improve breastfeeding rates, and decrease the risk of severe infection and hypothermia in LBW infants.

Recent research has also explored the potential benefits of early initiation of KMC, including initiation soon after birth rather than after stabilization. The World Health Organization Immediate Kangaroo Mother Care study evaluated continuous KMC initiated shortly after birth in infants with birth weights between 1.0 and 1.799 kg and suggested potential survival benefits. However, further evidence is needed to determine the effectiveness of early KMC initiation in relatively stable LBW infants in routine clinical settings, particularly in low-resource environments.

This randomized controlled trial aims to evaluate the effectiveness of early initiation of kangaroo mother care within the first 24 hours after birth compared with standard neonatal care practices in healthy low birth weight preterm infants. Participants randomized to the intervention arm will receive structured early KMC with caregiver skin-to-skin contact and breastfeeding support according to institutional protocols. Infants in the control group will receive standard neonatal care as practiced in the neonatal unit.

The study will be conducted at the neonatal care facilities of Services Hospital Lahore. By comparing early KMC with standard care, the trial aims to generate evidence regarding the feasibility and clinical impact of early KMC initiation in a tertiary care hospital in Pakistan. Findings from this study may contribute to strengthening neonatal care policies and support wider implementation of KMC programs in similar healthcare settings.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • New admission of singleton or twin (inborn or out-born)
  • Weight < 2000 g (as per study scale)
  • Age 1-24 h old when screening begins
  • Gestational age >30 weeks to <37 weeks
  • Mother or other caregiver available and willing to provide intervention

Exclusion criteria

  • Triplets who are all admitted to the study site
  • Congenital malformation not compatible with life or needing immediate surgical intervention
  • Severe jaundice
  • Seizures
  • Stable as assessed during cardio-respiratory screening
  • Severely unstable as assessed during cardio-respiratory screening or died during screening
  • Severe perinatal asphyxia
  • Babies require a ventilator or inotropic support
  • The mother is critically ill or unable to comply with the follow-up schedule
  • No study bed available
  • Neonates/mothers enrolled in another research study
  • No written informed consent from parent or caregiver within 24 h of admission.

Treatment and study plan

Kangaroo mother care

Other

Skin-to-skin contact was given for a minimum of 1 hour at a time and at least for 12 hrs./ day, duration was gradually increased to as long as comfortable to the mother and baby.

Standard Medical Care (SMC)

Other

In well baby nursery, under radiant warmer

Primary outcomes

  1. Number of neonatal deaths within 72 hours after enrollment

    Time frame: 0-72 hours of age

    Vital status will be assessed every 12 hours during hospital stay. Neonatal death is defined as cessation of breathing and circulation confirmed by attending physician.

  2. Number of neonatal deaths within 28 days of age

    Time frame: Enrollment to Day 28

    Vital status assessed every 12 hours during hospitalization and via home visit on Day 29.

  3. Length of hospital stay from enrollment to discharge

    Time frame: Enrollment to discharge

    Total days spent in nursery/KMC ward from admission to discharge as documented in hospital records.

Secondary outcomes

  1. Number of infants exclusively breastfed at 29 days of age

    Time frame: Day 29

    Assessed via 24-hour feeding recall during home visit. Exclusive breastfeeding means no other liquids or solids except prescribed medicines/supplements.

  2. Number of infants with clinically suspected sepsis during hospital stay

    Time frame: Enrollment to discharge/Day 28

    Suspected sepsis identified through 12-hourly clinical records and laboratory evaluation based on unit protocol.

Other outcomes

  1. Maternal satisfaction score with hospital care

    Time frame: At discharge

    Structured interview-based rating of overall hospital care experience by the mother.

  2. Maternal depressive symptoms using PHQ-9 scale

    Time frame: Day 29

    Mother scores ≥15 considered depressed as per PHQ-9 validated cutoff.

Sponsors and collaborators

Lead sponsor

University of Health Sciences Lahore

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 2, 2025
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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