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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

423 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-19

Study Completion Date

2017-08-12

Brief Summary

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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.

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Detailed Description

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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 (warm delivery rooms, immediate drying after birth, early and exclusive breastfeeding, postponement of bathing and weighing, and appropriate bundling) reduces the incidence of moderate hypothermia (32-36° C) or severe (\<32.0° C) 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, as practiced. The investigators are proposing two trials, one protocol for infants 32-36 6/7 weeks and one for infants who are ≥37 weeks gestational age (this one). This term infant trial will address the effectiveness of KMC in combination with plastic bags in decreasing hypothermia in preterm infants. The proposed trial will determine whether KMC with plastic bags prevents hypothermia in neonates born in a healthcare setting with limited resources where a high risk for hypothermia has been reported. Any intervention that decreases morbidity during the neonatal period has the potential to impact health beyond the neonatal period,and one that is highly cost-effective and easy to use is more likely to be implemented in the developing world.

Conditions

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Preterm Infant Hypothermia Neonatal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomization at birth followed by randomization at 1 hour

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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KMC & WHO protocol (0-1 hour)

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.

Group Type ACTIVE_COMPARATOR

KMC & WHO protocol (0-1 hour)

Intervention Type 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 (1-24 hours)

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.

Group Type ACTIVE_COMPARATOR

KMC & WHO protocol (1-24 hours)

Intervention Type OTHER

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

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

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.

Group Type EXPERIMENTAL

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

Intervention Type 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 (1-24 hours

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.

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

KMC & WHO protocol (1-24 hours)

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

Intervention Type OTHER

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

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Estimated gestational age ≥37 0/7 weeks
* Delivery in the hospital

Exclusion Criteria

* 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

Minimum Eligible Age

10 Minutes

Maximum Eligible Age

24 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No