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Kangaroo Mother Care With Plastic Bag (Trials 1A & 1B)

NCT03141736 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-12-16

No results posted yet for this study

Summary

The purpose of this study is to determine whether the combination of Kangaroo Mother Care (KMC) as continuously as possible together with the use of a plastic bag in combination with routine World Health Organization (WHO) thermoregulation care reduces the incidence of moderate (32-36° C) or severe (\<32.0° C) hypothermia in preterm infants ≥ 32 to 36 6/7 weeks of gestational age (GA) when compared to KMC as continuously as possible together with routine WHO thermoregulation care.

Conditions

Interventions

OTHER

KMC & WHO protocol (0-1 hour)

WHO thermoregulation care - warm delivery rooms, immediate drying after birth, early and exclusive breastfeeding, postponement of bathing and weighing, and appropriate bundling

OTHER

KMC, WHO protocol & bag (0-1 hour)

In addition infants will be placed in a plastic bag (clear polyethylene non-medical low-cost \[3 cents per bag\]

OTHER

KMC & WHO protocol (1-24 hours)

WHO thermoregulation care - warm delivery rooms, immediate drying after birth, early and exclusive breastfeeding, postponement of bathing and weighing, and appropriate bundling

OTHER

KMC, WHO protocol & bag (1-24 hours)

In addition infants will be placed in a plastic bag (clear polyethylene non-medical low-cost \[3 cents per bag\]

Sponsors & Collaborators

  • University Teaching Hospital, Lusaka, Zambia

    collaborator OTHER

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Colm P Travers, MD · University of Alabama at Birmingham

  • Waldemar A Carlo, MD · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Minutes
Max Age
2 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-19
Primary Completion
2025-10-12
Completion
2025-10-12

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Diseases

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 NCT03141736 on ClinicalTrials.gov