Kangaroo Mother Care With Plastic Bag (Trials 1A & 1B)

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Primary Purpose

Status

Withdrawn

Phase

Not Applicable

Locations

Zambia

Study Type

Interventional

Intervention

KMC & WHO protocol (0-1 hour)

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

KMC & WHO protocol (1-24 hours)

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

About this trial

This is an interventional prevention trial for Preterm Birth focused on measuring Infant, Newborn, Preterm, Hypothermia, Kangaroo, Plastic, Bag

Eligibility Criteria

10 Minutes - 2 Hours (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Estimated gestational age ≥32 0/7 - 36 6/7 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 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

Sites / Locations

University Teaching Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Arm Label

KMC & WHO protocol (0-1 hour)

KMC & WHO protocol (1-24 hours)

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

KMC, WHO protocol & bag (1-24 hours

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)

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)

Secondary Outcome Measures

Any hypothermia at 1 hour after birth (Phase 1A)

Any hypothermia (<36.5C) at 1 hour after birth

Any hypothermia at 24 hours or discharge (Phase 1B)

Any hypothermia (<36.5C) at 24 hours or discharge, whichever occurs first

Hyperthermia at 1 hour after birth (Phase 1A)

Hyperthermia (>38.0C) at 1 hour after birth

Hyperthermia at 24 hours or discharge (Phase 1B)

Hyperthermia (>38.0C) at 24 hours or discharge, whichever occurs first

Skin rash

Skin rash (at 1hour and before discharge)

Neonatal Intensive Care Unit admission

Neonatal Intensive Care Unit admission (at 1 hour and before discharge)

Respiratory distress syndrome

Diagnosis of respiratory distress syndrome (at 1 hour and before discharge)

Sepsis

Diagnosis of sepsis (at 1hour and before discharge)

Hypotension, hypoglycemia or seizure

Diagnosis of any of the following; hypotension, hypoglycemia or seizure (at 1hour and before discharge)

Death

Death (at 1hour and before discharge)

Maternal body temperature

Maternal body temperature in Celsius

Duration of KMC and plastic bag to infant's body temperature

Correlation analysis between duration of KMC +/- plastic bag in minutes to infant's body temperature in Celsius

Duration of KMC and plastic bag to infant's body temperature

Correlation analysis between duration of KMC +/- plastic bag in minutes to infant's body temperature in Celsius

Full Information

NCT ID

NCT03141736

First Posted

May 3, 2017

Last Updated

November 4, 2022

Sponsor

University of Alabama at Birmingham

Collaborators

University Teaching Hospital, Lusaka, Zambia

1. Study Identification

Unique Protocol Identification Number

NCT03141736

Brief Title

Kangaroo Mother Care With Plastic Bag (Trials 1A & 1B)

Official Title

Randomized Trials of Kangaroo Mother Care With Plastic Bag to Prevent Neonatal Hypothermia in Preterm Infants (Trial 1A and 1B)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Withdrawn

Why Stopped

Staff not available to commence study.

Study Start Date

November 19, 2024 (Anticipated)

Primary Completion Date

October 12, 2025 (Anticipated)

Study Completion Date

October 12, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Alabama at Birmingham

Collaborators

University Teaching Hospital, Lusaka, Zambia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

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 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, as practiced. The investigators are proposing two trials, one protocol for infants 32-36 6/7 weeks (this one) and one for infants who are ≥37 weeks gestational age. This preterm 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Preterm Birth, Hypothermia, Newborn

Keywords

Infant, Newborn, Preterm, Hypothermia, Kangaroo, Plastic, Bag

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

KMC & WHO protocol (0-1 hour)

Arm Type

Active Comparator

Arm Description

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.

Arm Title

KMC & WHO protocol (1-24 hours)

Arm Type

Active Comparator

Arm Description

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.

Arm Title

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

Arm Type

Experimental

Arm Description

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.

Arm Title

KMC, WHO protocol & bag (1-24 hours

Arm Type

Experimental

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

KMC & WHO protocol (0-1 hour)

Intervention Description

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

Intervention Name(s)

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

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

KMC & WHO protocol (1-24 hours)

Intervention Description

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

Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Moderate (32.0-35.9C) or severe (<32.0C) hypothermia at 1 hour after birth (via axillary temperature)

Time Frame

1 hour after birth

Title

Moderate or severe hypothermia at 24 hours or discharge (Phase 1B)

Description

Moderate (32.0-35.9C) or severe (<32.0C) hypothermia at 24 hours or discharge whichever occurs first (via axillary temperature)

Time Frame

1 to 24 hours after birth

Secondary Outcome Measure Information:

Title

Any hypothermia at 1 hour after birth (Phase 1A)

Description

Any hypothermia (<36.5C) at 1 hour after birth

Time Frame

1 hour after birth

Title

Any hypothermia at 24 hours or discharge (Phase 1B)

Description

Any hypothermia (<36.5C) at 24 hours or discharge, whichever occurs first

Time Frame

1 to 24 hours or discharge

Title

Hyperthermia at 1 hour after birth (Phase 1A)

Description

Hyperthermia (>38.0C) at 1 hour after birth

Time Frame

1 hour after birth

Title

Hyperthermia at 24 hours or discharge (Phase 1B)

Description

Hyperthermia (>38.0C) at 24 hours or discharge, whichever occurs first

Time Frame

1 to 24 hours or discharge

Title

Skin rash

Description

Skin rash (at 1hour and before discharge)

Time Frame