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

NCT07259486 | Completed DMC

• 1 other identifier: IRB/2022/921/SIMS
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Low Birth Weight; Premature Birth; Preterm Infant

Keywords

Kangaroo Mother Care; Early Kangaroo Mother Care; Skin-to-Skin Contact; Low Birth Weight Infants; Preterm Neonates; Prematurity; Neonatal Care; Breastfeeding Support

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Number of infants exclusively breastfed at 29 days of age

  Day 29

• Number of infants with clinically suspected sepsis during hospital stay

  Enrollment to discharge/Day 28

Other Outcomes (2)

• Maternal satisfaction score with hospital care

  At discharge

• Maternal depressive symptoms using PHQ-9 scale

  Day 29

Study Arms (2)

Kangaroo Mother Care (Group-I)

EXPERIMENTAL

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

Standard Method Care (Group-II)

ACTIVE COMPARATOR

Neonate in the SMC group was managed under a radiant warmer.

Other: Standard Medical Care (SMC)

Interventions

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.

Kangaroo Mother Care (Group-I)

Standard Medical Care (SMC) OTHER

In well baby nursery, under radiant warmer

Standard Method Care (Group-II)

Eligibility Criteria

• Age: 1 Hour - 24 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Health Sciences Lahore: lead

Study Sites (1)

National Hospital and Medical Centre

Lahore, Punjab Province, 56300, Pakistan

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Kangaroo-Mother Care Method

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Patient Positioning; Patient Care; Therapeutics; Infant Care; Child Care; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Medical Officer

Model Details: This randomized controlled trial study was conducted in low birth weight babies admitted in Services Hospital Lahore, Punjab, Pakistan. Inclusion criteria were neonate with birth weight 1250 to 1800 gm., gestational age \>30weeks to \<37 weeks and the hemodynamically stable after birth. A detailed history was taken from the mother/caregiver and from an obstetric record and then entered in the structured questionnaire. Gestational age was determined by best obstetric estimates and new Ballard score. Exclusion criteria were a major life-threatening congenital malformation, severe perinatal asphyxia, babies require a ventilator or inotropic support, the mother is critically ill or unable to comply with the follow-up schedule, parental refusal for KMC intervention. Eligible subjects were selected as per inclusion and exclusion criteria. The subjects were divided into two groups; Kangaroo Mother Care (Group-I) and Standard Method Care (Group-II). Randomization was achieved by lottery techniqu

Study Record Dates

• First Submitted: September 28, 2025
• First Posted: December 2, 2025
• Study Start: March 1, 2022
• Primary Completion: February 28, 2024
• Study Completion: March 31, 2024
• Last Updated: March 11, 2026

Record last verified: 2026-03

Locations

PA (1)