Kangaroo Mother Care With Plastic Bag (Trials 2A & 2B)

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 term infants ≥ 37 0/7 weeks of gestational age (GA) when compared to KMC as continuously as possible together with routine WHO thermoregulation care.

Conditions

• Preterm Infant
• Hypothermia Neonatal

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 nonmedical low-cost \[3 cents per bag\] linear low-density bag measuring 10 × 8 × 24 in. and 1.2 mil thick) that will cover the infant's torso and lower extremities.

OTHER

KMC & WHO protocol (1-24 hours)

WHO thermoregulation care - warm delivery rooms, immediate drying after birth, early and exclusive

OTHER

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

In addition infants will be placed in a plastic bag (clear polyethylene nonmedical 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

24 Hours

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-05-19

Primary Completion

2017-08-12

Completion

2017-08-12

Countries

• Zambia

Study Locations