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Early Kangaroo Mother Care in Gambian Hospitalised Unstable Neonates

NCT03555981 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 279

Last updated 2026-04-16

Study results available
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Summary

The mortality effect of kangaroo mother care in stable newborns \<2000g is well established but mortality effect in unstable newborns is not conclusively known. This pragmatic clinical trial aims to investigate the mortality and clinical effects of early continuous Kangaroo Mother Care (KMC) compared to standard care in mild-moderately unstable neonates \<2000g in a resource limited hospital setting.

Conditions

  • Preterm Infant
  • Hypothermia, Newborn
  • Death
  • Kangaroo Mother Care
  • Infection, Bacterial

Interventions

OTHER

Early Kangaroo Mother Care

Continuous skin-to-skin contact between baby and mother/caregiver started within 24h of hospital admission

OTHER

Standard care

Incubator or radiant heater care until stable, off oxygen and \>24h of admission, at which point will start intermittent or continuous kangaroo mother care

Sponsors & Collaborators

  • Wellcome Trust

    collaborator OTHER

  • Medical Research Council Unit, The Gambia

    collaborator OTHER

  • London School of Hygiene and Tropical Medicine

    lead OTHER

Principal Investigators

  • Helen C Brotherton, MBChB · London School of Hygiene and Tropical Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-05-20
Primary Completion
2020-04-20
Completion
2020-04-20

Countries

  • The Gambia

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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 NCT03555981 on ClinicalTrials.gov