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.

Study Overview

• Status: Completed
• Conditions: Premature Birth; Low Birth Weight; Preterm Infant
• Intervention / Treatment: Other: Kangaroo Mother Care; Other: Standard Medical Care (SMC)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab Province
    • Lahore, Punjab Province, Pakistan, 56300
      • National Hospital and Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Kangaroo Mother Care (Group-I); In the KMC group mothers were explained detail about KMC adoption in the presence of their family. KMC was initiated as soon as the baby was stable. If the mother is not available initially any of the family members can start KMC. The mother provided skin to skin contact in upright position dressed in a cap, socks, and diaper and supported in the bottom with a sling/binder. Adequate privacy was ensured. Comfortable chairs and beds were provided to the mothers practicing KMC in the nursery. 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. When the baby is not in KMC, the baby was placed in the cot with adequately clothed and covered. A "KMC" chart was given to the mother to keep a record of the duration of kangaroo care provided. If the mother is unable to fill up the chart, it was done by a close family member.	Other: Kangaroo Mother Care; 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.
Active Comparator: Standard Method Care (Group-II); Neonate in the SMC group was managed under a radiant warmer.	Other: Standard Medical Care (SMC); In well baby nursery, under radiant warmer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of neonatal deaths within 72 hours after enrollment	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.	0-72 hours of age
Number of neonatal deaths within 28 days of age	Vital status assessed every 12 hours during hospitalization and via home visit on Day 29.	Enrollment to Day 28
Length of hospital stay from enrollment to discharge	Total days spent in nursery/KMC ward from admission to discharge as documented in hospital records.	Enrollment to discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of infants exclusively breastfed at 29 days of age	Assessed via 24-hour feeding recall during home visit. Exclusive breastfeeding means no other liquids or solids except prescribed medicines/supplements.	Day 29
Number of infants with clinically suspected sepsis during hospital stay	Suspected sepsis identified through 12-hourly clinical records and laboratory evaluation based on unit protocol.	Enrollment to discharge/Day 28

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal satisfaction score with hospital care	Structured interview-based rating of overall hospital care experience by the mother.	At discharge
Maternal depressive symptoms using PHQ-9 scale	Mother scores ≥15 considered depressed as per PHQ-9 validated cutoff.	Day 29

Collaborators and Investigators

• Sponsor: University of Health Sciences Lahore

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): February 28, 2024
• Study Completion (Actual): March 31, 2024

Study Registration Dates

• First Submitted: September 28, 2025
• First Submitted That Met QC Criteria: November 26, 2025
• First Posted (Actual): December 2, 2025

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 8, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Prematurity; Breastfeeding Support; Kangaroo Mother Care; Preterm Neonates; Neonatal Care; Skin-to-Skin Contact; Early Kangaroo Mother Care; Low Birth Weight Infants
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Premature Birth; Therapeutics; Patient Care; Health Services; Health Care Facilities Workforce and Services; Infant Care; Child Care; Patient Positioning; Kangaroo-Mother Care Method
• Other Study ID Numbers: IRB/2022/921/SIMS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Due to confidentiality

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No