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

Study Overview
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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.

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.

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

Conditions
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Preterm Infant, Hypothermia Neonatal

Intervention / Treatment
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* Other: KMC & WHO protocol (0-1 hour)
* Other: KMC, WHO protocol & bag (0-1 hour)
* Other: KMC & WHO protocol (1-24 hours)
* Other: KMC, WHO protocol & bag (1-24 hours)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Minutes
Maximum Age: 24 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomization at birth followed by randomization at 1 hour
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: KMC & WHO protocol (0-1 hour)<br>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)<br>* WHO thermoregulation care - warm delivery rooms, immediate drying after birth, early and exclusive breastfeeding, postponement of bathing and weighing, and appropriate bundling.<br>|
| Active Comparator: KMC & WHO protocol (1-24 hours)<br>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)<br>* WHO thermoregulation care - warm delivery rooms, immediate drying after birth, early and exclusive<br>|
| Experimental: KMC, WHO protocol & bag (0-1 hour)<br>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)<br>* 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.<br>|
| Experimental: KMC, WHO protocol & bag (1-24 hours<br>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)<br>* In addition infants will be placed in a plastic bag (clear polyethylene nonmedical low-cost [3 cents per bag]<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any hypothermia at 1 hour after birth (Phase 2A) | Any hypothermia (<36.5C) at 1 hour after birth | 1 hour after birth | 
| Any hypothermia at 1 hour after birth (Phase 2B) | 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) | Hyperthermia (>38.0C) at 1 hour after birth | 1 hour after birth | 
| Hyperthermia at 1 hour after birth (Phase 2B) | Hyperthermia (>38.0C) at 24 hours or discharge, whichever occurs first | 1 to 24 hours or discharge | 
| Skin rash | Skin rash (at 1 hour and before discharge) | 1 hour to 24 hours or discharge, or whichever occurs first | 
| Neonatal Intensive Care Unit admission | 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 | Diagnosis of respiratory distress syndrome (at 1 hour and before discharge) | 1 hour to 24 hours or discharge, or whichever occurs first | 
| Sepsis | Diagnosis of sepsis (at 1 hour and before discharge) | 1 hour to 24 hours or discharge, or whichever occurs first | 
| Hypotension, hypoglycemia or seizure | 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 | Death (at 1 hour and before discharge) | 1 hour to 24 hours or discharge, or whichever occurs first | 
| Maternal body temperature | 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 | 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 | 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] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infant, Newborn, Preterm, Hypothermia, Kangaroo, Plastic, Bag