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Kangaroo Mother Care With Plastic Bag (Trials 1A & 1B)
Randomized Trials of Kangaroo Mother Care With Plastic Bag to Prevent Neonatal Hypothermia in Preterm Infants (Trial 1A and 1B)
1 other identifier
interventional
N/A
0 countries
N/A
Brief 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.
Trial Health
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Started Nov 2024
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 3, 2017
CompletedFirst Posted
Study publicly available on registry
May 5, 2017
CompletedStudy Start
First participant enrolled
November 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 12, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 12, 2025
CompletedDecember 16, 2025
November 1, 2022
11 months
May 3, 2017
December 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Moderate or severe hypothermia at 1 hour after birth (Phase 1A)
Moderate (32.0-35.9C) or severe (\<32.0C) hypothermia at 1 hour after birth (via axillary temperature)
1 hour after birth
Moderate or severe hypothermia at 24 hours or discharge (Phase 1B)
Moderate (32.0-35.9C) or severe (\<32.0C) hypothermia at 24 hours or discharge whichever occurs first (via axillary temperature)
1 to 24 hours after birth
Secondary Outcomes (13)
Any hypothermia at 1 hour after birth (Phase 1A)
1 hour after birth
Any hypothermia at 24 hours or discharge (Phase 1B)
1 to 24 hours or discharge
Hyperthermia at 1 hour after birth (Phase 1A)
1 hour after birth
Hyperthermia at 24 hours or discharge (Phase 1B)
1 to 24 hours or discharge
Skin rash
1hour to 24 hours or discharge, or whichever occurs first
- +8 more secondary outcomes
Study Arms (4)
KMC & WHO protocol (0-1 hour)
ACTIVE COMPARATORThe combination of Kangaroo Mother Care (KMC) as continuously as possible together with routine World Health Organization (WHO) thermoregulation care (warm delivery rooms, immediate drying after birth, early and exclusive breastfeeding, postponement of bathing and weighing, and appropriate bundling.
KMC & WHO protocol (1-24 hours)
ACTIVE COMPARATORThe combination of Kangaroo Mother Care (KMC) as continuously as possible together with routine World Health Organization (WHO) thermoregulation care (warm delivery rooms, immediate drying after birth, early and exclusive breastfeeding, postponement of bathing and weighing, and appropriate bundling.
KMC, WHO protocol & bag (0-1 hour)
EXPERIMENTALThe 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 (warm delivery rooms, immediate drying after birth, early and exclusive breastfeeding, postponement of bathing and weighing, and appropriate bundling.
KMC, WHO protocol & bag (1-24 hours
EXPERIMENTALThe 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 (warm delivery rooms, immediate drying after birth, early and exclusive breastfeeding, postponement of bathing and weighing, and appropriate bundling.
Interventions
WHO thermoregulation care - warm delivery rooms, immediate drying after birth, early and exclusive breastfeeding, postponement of bathing and weighing, and appropriate bundling
In addition infants will be placed in a plastic bag (clear polyethylene non-medical low-cost \[3 cents per bag\]
WHO thermoregulation care - warm delivery rooms, immediate drying after birth, early and exclusive breastfeeding, postponement of bathing and weighing, and appropriate bundling
In addition infants will be placed in a plastic bag (clear polyethylene non-medical low-cost \[3 cents per bag\]
Eligibility Criteria
You may qualify if:
- Estimated gestational age ≥32 0/7 - 36 6/7 weeks
- Delivery in the hospital
You may not qualify if:
- Abdominal wall defect or myelomeningocele
- Major congenital anomalies
- Blistering skin disorder
- Clinically unstable mothers secondary to cardiovascular and pulmonary conditions
- Infants requiring respiratory support beyond 10 minutes after birth
- Infant requiring NICU admission
- C/section
- Multiple gestation if the last delivering infant is not born within 10 minutes from the time of birth of the first infant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Colm P Travers, MD
University of Alabama at Birmingham
- STUDY DIRECTOR
Waldemar A Carlo, MD
University of Alabama at Birmingham
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
May 3, 2017
First Posted
May 5, 2017
Study Start
November 19, 2024
Primary Completion
October 12, 2025
Study Completion
October 12, 2025
Last Updated
December 16, 2025
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share