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

NCT03141723 | Completed DMC

• 1 other identifier: F150807003
• Study Type: interventional
• Target: 423
• Locations: 1 country
• Sites: 1

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 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

Keywords

Infant; Newborn; Preterm; Hypothermia; Kangaroo; Plastic; Bag

Outcome Measures

Primary Outcomes (2)

• Moderate or severe hypothermia at 1 hour after birth (Phase 2A)

  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 2B)

  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 2A)

  1 hour after birth

• Any hypothermia at 1 hour after birth (Phase 2B)

  1 to 24 hours or discharge

• Hyperthermia at 1 hour after birth (Phase 2A)

  1 hour after birth

• Hyperthermia at 1 hour after birth (Phase 2B)

  1 to 24 hours or discharge

• Skin rash

  1 hour to 24 hours or discharge, or whichever occurs first

Study Arms (4)

KMC & WHO protocol (0-1 hour)

ACTIVE COMPARATOR

The 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.

Other: KMC & WHO protocol (0-1 hour)

KMC & WHO protocol (1-24 hours)

ACTIVE COMPARATOR

The 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.

Other: KMC & WHO protocol (1-24 hours)

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

EXPERIMENTAL

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 (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)

KMC, WHO protocol & bag (1-24 hours

EXPERIMENTAL

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 (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)

Interventions

KMC & WHO protocol (0-1 hour) OTHER

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 (0-1 hour)

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

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.

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

KMC & WHO protocol (1-24 hours) OTHER

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

KMC & WHO protocol (1-24 hours)

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

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

KMC, WHO protocol & bag (1-24 hours

Eligibility Criteria

• Age: 10 Minutes - 24 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Estimated gestational age ≥37 0/7 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 Neonatal Intensive Care Unit admission
• Cesarean section
• Multiple gestation if the last delivering infant is not born within 10 minutes from the time of birth of the first infant

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• University Teaching Hospital, Lusaka, Zambia: collaborator

Study Sites (1)

University Teaching Hospital

Lusaka, Zambia

Location

Related Publications (1)

• Travers CP, Ramani M, Gentle SJ, Schuyler A, Brown C, Dills MM, Davis CB, Mwenechanya M, Chomba E, Aban I, Manasyan A, Ambalavanan N, Carlo WA. Early Skin-to-Skin Care with a Polyethylene Bag for Neonatal Hypothermia: A Randomized Clinical Trial. J Pediatr. 2021 Apr;231:55-60.e1. doi: 10.1016/j.jpeds.2020.12.064. Epub 2020 Dec 26.

  PMID: 33373672 DERIVED

MeSH Terms

Conditions

Premature Birth; Hypothermia

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Colm P Travers, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• Waldemar A Carlo, MD

  University of Alabama at Birmingham

  STUDY DIRECTOR

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

Model Details: Randomization at birth followed by randomization at 1 hour

Study Record Dates

• First Submitted: May 3, 2017
• First Posted: May 5, 2017
• Study Start: May 19, 2017
• Primary Completion: August 12, 2017
• Study Completion: August 12, 2017
• Last Updated: June 18, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)