Completed

A Randomized Trial of Kangaroo Mother Care to Prevent Neonatal Hypothermia - Trials 1A & 1B

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What is being tested

Continuous Kangaroo Mother Care to 1 hour after birth

+ Standard Kangaroo Mother Care to 1 hour after birth

+ Continuous Kangaroo Mother Care to discharge

Other
Who is being recruted

Hyperthermia+4

+ Body Temperature Changes

+ Hypothermia

+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-Controlled
Interventional
Study Start: June 2014
See protocol details

Summary

Principal SponsorUniversity of Alabama at Birmingham
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2014

Actual date on which the first participant was enrolled.

The overall hypothesis is that better adherence to Kangaroo Mother Care (KMC) in combination with existing World Health Organization (WHO) thermoregulation care (warm delivery rooms, immediate drying after birth, KMC whenever possible, early and exclusive breastfeeding, postponement of bathing and weighing, appropriate bundling, and use of air incubator, radiant warmer, or heat mattress if the neonate develops hypothermia) will reduce the incidence of moderate hypothermia (32-36 degrees C) or severe hypothermia (<32.0 degrees C) in preterm infants (32-36 6/7 weeks of gestational age) when compared with routine WHO thermoregulation alone.

Official TitleA Randomized Trial of Kangaroo Mother Care to Prevent Neonatal Hypothermia - Trials 1A & 1B
NCT02189746
Principal SponsorUniversity of Alabama at Birmingham
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

140 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

HyperthermiaBody Temperature ChangesHypothermiaSigns and SymptomsPathological Conditions, Signs and SymptomsWounds and InjuriesHeat Stress Disorders

Criteria

2 inclusion criteria required to participate
Estimated gestational age 32-36 6/7 weeks
Delivery in the hospital
3 exclusion criteria prevent from participating
Abdominal wall defect or myelomeningocele
Major congenital anomalies
Blistering skin disorder

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
In addition to standard WHO thermoregulation care which includes warm delivery rooms, immediate drying, Kangaroo Mother Care (KMC) whenever possible, early and exclusive breastfeeding, postponed bathing and weighing if needed, appropriate bundling and placing the infant in air incubator, radiant heater, or heat mattress if the infant develops hypothermia, the infants will receive continuous KMC most of the time possible from birth to one hour after birth.

Group II

Sham
Infants will receive standard WHO thermoregulation care which includes warm delivery rooms, immediate drying, Kangaroo Mother Care (KMC) whenever possible, early and exclusive breastfeeding, postponed bathing and weighing if needed, appropriate bundling and placing the infant in air incubator, radiant heater, or heat mattress if the infant develops hypothermia from birth to 1 hour after birth.

Group III

Active Comparator
In addition to standard WHO thermoregulation care which includes warm delivery rooms, immediate drying, Kangaroo Mother Care (KMC) whenever possible, early and exclusive breastfeeding, postponed bathing and weighing if needed, appropriate bundling and placing the infant in air incubator, radiant heater, or heat mattress if the infant develops hypothermia, the infants will receive continuous KMC most of the time possible from one hour after birth to discharge.

Group IV

Sham
Infants will receive standard WHO thermoregulation care which includes warm delivery rooms, immediate drying, Kangaroo Mother Care (KMC) whenever possible, early and exclusive breastfeeding, postponed bathing and weighing if needed, appropriate bundling and placing the infant in air incubator, radiant heater, or heat mattress if the infant develops hypothermia from 1 hour after birth to discharge.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University Teaching Hospital

Lusaka, ZambiaOpen University Teaching Hospital in Google Maps
CompletedOne Study Center