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

June 14, 2018 updated by: Colm Travers, University of Alabama at Birmingham

Randomized Trials of Kangaroo Mother Care With Plastic Bag to Prevent Neonatal Hypothermia in Preterm Infants (Trial 2A and 2B)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
423

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Zambia
      • Lusaka, Zambia
        • University Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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.
Other: 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.
Active Comparator: 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.
Other: KMC & WHO protocol (1-24 hours)
WHO thermoregulation care - warm delivery rooms, immediate drying after birth, early and exclusive
Experimental: 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.
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.
Experimental: 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.
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]

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Moderate or severe hypothermia at 1 hour after birth (Phase 2A)
Time Frame: 1 hour after birth
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)
Time Frame: 1 to 24 hours after birth
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Any hypothermia at 1 hour after birth (Phase 2A)
Time Frame: 1 hour after birth
Any hypothermia (<36.5C) at 1 hour after birth
1 hour after birth
Any hypothermia at 1 hour after birth (Phase 2B)
Time Frame: 1 to 24 hours or discharge
Any hypothermia (<36.5C) at 24 hours or discharge, whichever occurs first
1 to 24 hours or discharge
Hyperthermia at 1 hour after birth (Phase 2A)
Time Frame: 1 hour after birth
Hyperthermia (>38.0C) at 1 hour after birth
1 hour after birth
Hyperthermia at 1 hour after birth (Phase 2B)
Time Frame: 1 to 24 hours or discharge
Hyperthermia (>38.0C) at 24 hours or discharge, whichever occurs first
1 to 24 hours or discharge
Skin rash
Time Frame: 1 hour to 24 hours or discharge, or whichever occurs first
Skin rash (at 1 hour and before discharge)
1 hour to 24 hours or discharge, or whichever occurs first
Neonatal Intensive Care Unit admission
Time Frame: 1 hour to 24 hours or discharge, or whichever occurs first
Neonatal Intensive Care Unit admission (at 1 hour and before discharge)
1 hour to 24 hours or discharge, or whichever occurs first
Respiratory distress syndrome
Time Frame: 1 hour to 24 hours or discharge, or whichever occurs first
Diagnosis of respiratory distress syndrome (at 1 hour and before discharge)
1 hour to 24 hours or discharge, or whichever occurs first
Sepsis
Time Frame: 1 hour to 24 hours or discharge, or whichever occurs first
Diagnosis of sepsis (at 1 hour and before discharge)
1 hour to 24 hours or discharge, or whichever occurs first
Hypotension, hypoglycemia or seizure
Time Frame: 1 hour to 24 hours or discharge, or whichever occurs first
Diagnosis of any of the following; hypotension, hypoglycemia or seizure (at 1hour and before discharge)
1 hour to 24 hours or discharge, or whichever occurs first
Death
Time Frame: 1 hour to 24 hours or discharge, or whichever occurs first
Death (at 1 hour and before discharge)
1 hour to 24 hours or discharge, or whichever occurs first
Maternal body temperature
Time Frame: At birth, at 1 hour, and every four hours until 24 hours or discharge, whichever occurs first
Maternal body temperature in Celsius
At birth, at 1 hour, and every four hours until 24 hours or discharge, whichever occurs first
Duration of KMC and plastic bag to infant's body temperature
Time Frame: During first 1 hour
Correlation analysis between duration of KMC +/- plastic bag in minutes to infant's body temperature in Celsius
During first 1 hour
Duration of KMC and plastic bag to infant's body temperature
Time Frame: During first 24 hours or discharge, or whichever occurs first]
Correlation analysis between duration of KMC +/- plastic bag in minutes to infant's body temperature in Celsius
During first 24 hours or discharge, or whichever occurs first]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alabama at Birmingham

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Teaching Hospital, Lusaka, Zambia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 19, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 12, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 12, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 3, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 5, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • F150807003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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