- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03141736
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)
Study Overview
Status
Conditions
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.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Lusaka, Zambia
- University Teaching Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
WHO thermoregulation care - warm delivery rooms, immediate drying after birth, early and exclusive breastfeeding, postponement of bathing and weighing, and appropriate bundling
|
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.
|
In addition infants will be placed in a plastic bag (clear polyethylene non-medical low-cost [3 cents per bag]
|
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.
|
In addition infants will be placed in a plastic bag (clear polyethylene non-medical low-cost [3 cents per bag]
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Moderate or severe hypothermia at 1 hour after birth (Phase 1A)
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 1B)
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
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Any hypothermia at 1 hour after birth (Phase 1A)
Time Frame: 1 hour after birth
|
Any hypothermia (<36.5C) at 1 hour after birth
|
1 hour after birth
|
Any hypothermia at 24 hours or discharge (Phase 1B)
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 1A)
Time Frame: 1 hour after birth
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Hyperthermia (>38.0C) at 1 hour after birth
|
1 hour after birth
|
Hyperthermia at 24 hours or discharge (Phase 1B)
Time Frame: 1 to 24 hours or discharge
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Hyperthermia (>38.0C) at 24 hours or discharge, whichever occurs first
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1 to 24 hours or discharge
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Skin rash
Time Frame: 1hour to 24 hours or discharge, or whichever occurs first
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Skin rash (at 1hour and before discharge)
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1hour to 24 hours or discharge, or whichever occurs first
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Neonatal Intensive Care Unit admission
Time Frame: 1hour to 24 hours or discharge, or whichever occurs first
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Neonatal Intensive Care Unit admission (at 1 hour and before discharge)
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1hour to 24 hours or discharge, or whichever occurs first
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Respiratory distress syndrome
Time Frame: 1hour to 24 hours or discharge, or whichever occurs first
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Diagnosis of respiratory distress syndrome (at 1 hour and before discharge)
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1hour to 24 hours or discharge, or whichever occurs first
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Sepsis
Time Frame: 1hour to 24 hours or discharge, or whichever occurs first
|
Diagnosis of sepsis (at 1hour and before discharge)
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1hour to 24 hours or discharge, or whichever occurs first
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Hypotension, hypoglycemia or seizure
Time Frame: 1hour to 24 hours or discharge, or whichever occurs first
|
Diagnosis of any of the following; hypotension, hypoglycemia or seizure (at 1hour and before discharge)
|
1hour to 24 hours or discharge, or whichever occurs first
|
Death
Time Frame: 1hour to 24 hours or discharge, or whichever occurs first
|
Death (at 1hour and before discharge)
|
1hour to 24 hours or discharge, or whichever occurs first
|
Maternal body temperature
Time Frame: At birth, at 1 hour, every four hours until 24 hours or discharge, whichever occurs first
|
Maternal body temperature in Celsius
|
At birth, at 1 hour, 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 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
Collaborators
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- F150807004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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