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Kangaroo Mother Care Before Stabilisation Amongst Low Birth Weight Neonates in Africa

NCT02811432 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2221

Last updated 2026-01-08

Study results available
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Summary

We will conduct an individually randomised, controlled, superiority trial with two parallel groups; an intervention arm allocated to receive KMC and a control arm receiving 'standard' care. The primary aim is to examine the impact of KMC initiated before stabilisation on mortality within 7 days relative to standard care amongst neonates ≤2000g at four hospitals in Uganda. We hypothesise that neonates in the arm allocated to receive KMC before stabilisation will have a 25% overall reduction in mortality within 7 days compared to neonates allocated to receive standard care.

Conditions

  • Kangaroo Mother Care
  • Preterm Infant
  • Death; Neonatal
  • Hypothermia, Newborn

Interventions

OTHER

Kangaroo mother care

Skin-to-skin care (target: at least 18 hours per day)

OTHER

Standard care

Incubator or radiant warmer until neonate meets stability criteria; once stable (WHO indication for KMC certain), the baby can transition to routine (intermittent) KMC

Sponsors & Collaborators

  • MRC/UVRI and LSHTM Uganda Research Unit

    collaborator OTHER

  • Makerere University

    collaborator OTHER

  • London School of Hygiene and Tropical Medicine

    lead OTHER

Principal Investigators

  • Joy E. Lawn, BMBS MPH PhD · London School of Hygiene and Tropical Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Hour
Max Age
48 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-13
Primary Completion
2022-09-30
Completion
2022-09-30

Countries

  • Uganda

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02811432 on ClinicalTrials.gov