NCT07736274

Brief Summary

Kangaroo Mother Care is a novel intervention known to improve survival, nutrition and prevent infections. Kangaroo Mother Care encompasses prolonged skin-to-skin contact between the mother and the baby and exclusive breastfeeding till the end of neonatal period or until the baby wriggles out, whichever is earlier.Studies have shown that kangaroo mother care has benefits for infants and mothers, including reduction in infant mortality rate, maintenance of the neonate's temperature and promoting breastfeeding. Kangaroo mother care also improves the infant's respiratory rate, oxygen saturation, weight gain, sleeping condition and physical growth. It has a positive effect on physical growth and motor development of newborns. Kangaroo mother care decreases the neonates need for phototherapy and repeated admission for neonatal jaundice in low birth weight infants. The objective of study is to compare the outcome with and without kangaroo mother care in neonates with low birth weight.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Sep 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 30, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

July 30, 2026

Status Verified

July 1, 2026

Enrollment Period

3 months

First QC Date

July 25, 2026

Last Update Submit

July 25, 2026

Conditions

Keywords

NeonatesKangaroo Mother CareBirth weight

Outcome Measures

Primary Outcomes (3)

  • Mean Weight Gain

    It will be calculated in terms of g/day as difference in weight before and after 40 days of trial, divided by 40 (number of days)

    40 days

  • Mean Head Circumference Gain

    It will be calculated in terms of cm/week as difference in weight before and after 40 days of trial, divided by 6 (weeks during 40 days)

    6 weeks

  • Hypothermia

    It will be labeled if body temperature falls below 98.6oF at any point during follow-up of 40 days

    40 days

Study Arms (2)

Group A, neonates will be given kangaroo mother care

EXPERIMENTAL
Behavioral: Kangaroo Mother Care

Group B, neonates will be given conventional neonatal care

ACTIVE COMPARATOR
Other: Conventional Neonatal Care

Interventions

Kangaroo Mother Care encompasses prolonged skin-to-skin contact between the mother and the baby and exclusive breastfeeding till the end of neonatal period or until the baby wriggles out, whichever is earlier

Group A, neonates will be given kangaroo mother care

Conventional pharmacotherapy and supportive care provided in low birth weight neonates

Group B, neonates will be given conventional neonatal care

Eligibility Criteria

Age1 Hour - 6 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Neonates of age 1-6 hours, both genders Delivered \>32 weeks of gestation (as per maternal record) Delivered either via cesarean section or vaginal delivery With low birth weight (1500-2000 grams)

You may not qualify if:

  • Children with major congenital disorder, cleft lip and palate, cyanotic heart disease, congenital anomaly,
  • Having chromosomal abnormality or Down's score \>7 at admission
  • Neonates of birth weight \<1500 grams, need NICU admission for surfactant or resuscitation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PNS Shifa Hospital Karachi

Karachi, Sindh, 75557, Pakistan

Location

MeSH Terms

Conditions

Birth Weight

Interventions

Kangaroo-Mother Care Method

Condition Hierarchy (Ancestors)

Body WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient PositioningPatient CareTherapeuticsInfant CareChild CareHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

Dr Hina Baby, MBBS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

July 25, 2026

First Posted

July 30, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

July 30, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations