Kangaroo Mother Care to Prevent Hypothermia in Preterm Infants

Study Overview
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Brief Summary
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The overall hypothesis is that better adherence to Kangaroo Mother Care (KMC) in combination with existing WHO thermoregulation care will reduce the incidence of moderate hypothermia (32-36 degrees C) or severe hypothermia (<32.0 degrees C) in preterm infants (32-36 6/7 weeks of gestational age) when compared with routine WHO thermoregulation alone.

Detailed Description
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The overall hypothesis is that better adherence to Kangaroo Mother Care (KMC) in combination with existing World Health Organization (WHO) thermoregulation care (warm delivery rooms, immediate drying after birth, KMC whenever possible, early and exclusive breastfeeding, postponement of bathing and weighing, appropriate bundling, and use of air incubator, radiant warmer, or heat mattress if the neonate develops hypothermia) will reduce the incidence of moderate hypothermia (32-36 degrees C) or severe hypothermia (<32.0 degrees C) in preterm infants (32-36 6/7 weeks of gestational age) when compared with routine WHO thermoregulation alone.

Official Title
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A Randomized Trial of Kangaroo Mother Care to Prevent Neonatal Hypothermia - Trials 1A & 1B

Conditions
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Hypothermia, Newborn

Intervention / Treatment
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* Other: Continuous Kangaroo Mother Care to 1 hour after birth
* Other: Standard Kangaroo Mother Care to 1 hour after birth
* Other: Continuous Kangaroo Mother Care to discharge
* Other: Standard Kangaroo Mother Care to discharge


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Estimated gestational age 32-36 6/7 weeks Delivery in the hospital Exclusion Criteria: Abdominal wall defect or myelomeningocele Major congenital anomalies Blistering skin disorder

Ages Eligible for Study
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Minimum Age: 1 Minute
Maximum Age: 8 Weeks

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Continuous Kangaroo Mother Care to 1 hour after birth<br>In addition to standard WHO thermoregulation care which includes warm delivery rooms, immediate drying, Kangaroo Mother Care (KMC) whenever possible, early and exclusive breastfeeding, postponed bathing and weighing if needed, appropriate bundling and placing the infant in air incubator, radiant heater, or heat mattress if the infant develops hypothermia, the infants will receive continuous KMC most of the time possible from birth to one hour after birth. | Other: Continuous Kangaroo Mother Care to 1 hour after birth<br>* Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible until 1 hour of birth. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (>38 degrees Celsius), the infant will be removed from KMC and routine bundling practices will be used. The infant's temperature will be taken via axillae with a digital thermometer at one hour of age.<br>|
| Sham Comparator: Standard Kangaroo Mother Care to 1 hour after birth<br>Infants will receive standard WHO thermoregulation care which includes warm delivery rooms, immediate drying, Kangaroo Mother Care (KMC) whenever possible, early and exclusive breastfeeding, postponed bathing and weighing if needed, appropriate bundling and placing the infant in air incubator, radiant heater, or heat mattress if the infant develops hypothermia from birth to 1 hour after birth. | Other: Standard Kangaroo Mother Care to 1 hour after birth<br>* Infants will receive the standard WHO thermoregulation care of Kangaroo Mother Care for as much as possible until 1 hour of birth, without additional encouragement per study personnel. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (>38 degrees Celsius), the infant will receive standard care which may include removal from KMC and use of routine bundling practices. The infant's temperature will be taken via axillae with a digital thermometer at one hour of age.<br>|
| Active Comparator: Continuous Kangaroo Mother Care to discharge<br>In addition to standard WHO thermoregulation care which includes warm delivery rooms, immediate drying, Kangaroo Mother Care (KMC) whenever possible, early and exclusive breastfeeding, postponed bathing and weighing if needed, appropriate bundling and placing the infant in air incubator, radiant heater, or heat mattress if the infant develops hypothermia, the infants will receive continuous KMC most of the time possible from one hour after birth to discharge. | Other: Continuous Kangaroo Mother Care to discharge<br>* Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from one hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (>38 degrees Celsius), the infant will be removed from KMC and routine bundling practices will be used. The infant's temperature will be taken via axillae with a digital thermometer at one hour of age and again at discharge or 24 hours whichever occurs first.<br>|
| Sham Comparator: Standard Kangaroo Mother Care to discharge<br>Infants will receive standard WHO thermoregulation care which includes warm delivery rooms, immediate drying, Kangaroo Mother Care (KMC) whenever possible, early and exclusive breastfeeding, postponed bathing and weighing if needed, appropriate bundling and placing the infant in air incubator, radiant heater, or heat mattress if the infant develops hypothermia from 1 hour after birth to discharge. | Other: Standard Kangaroo Mother Care to discharge<br>* Infants will receive the standard WHO thermoregulation care without additional encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from 1 hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (>38 degrees Celsius), standard treatment will be given which may include removal from KMC and use of routine bundling practices. The infant's temperature will be taken via axillae with a digital thermometer at one hour of age and again at discharge or 24 hours whichever occurs first.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Axillary temperature < 36.0 degrees Celsius | Temperature taken per axilla for one minute | Time of birth to 1 hour | 
| Axillary Temperature < 36.0 degrees Celsius | Temperature taken per axilla for one minute | At discharge or 24 hours after birth (whichever is first) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Measure of extremity blood pressure per cuff taken during nursery stay. | Duration of hospitalization-expected average of 4 weeks | 
| Blood glucose | Measure of blood glucose per laboratory value taken per heelstick | Duration of hospitalization-expected average of 4 weeks | 
| Seizure | Seizure activity diagnosed by medical doctor or nurse. No electroencephalogram will be done. | Duration of hospitalization-expected average of 4 weeks | 
| Respiratory Distress Syndrome (RDS) | Documentation of increased work of breathing, retractions, and need for oxygen, intubation or surfactant | Duration of hospitalization-expected average of 4 weeks | 
| Sepsis | Culture proven or culture negative clinically treated course consistent with sepsis | Duration of hospitalization-expected average of 4 weeks | 
| Neonatal Intensive Care Unit Admission | Any admission to NICU for need for higher level care | Duration of hospitalization-expected average of 4 weeks | 
| Death | Cardiorespiratory failure | Duration of hospitalization-expected average of 4 weeks | 
| Any Axillary Temperature < 36.0 degrees Celsius | Temperature taken per axilla for one minute | Duration of hospitalization-expected average of 4 weeks | 
| Duration of Kangaroo Mother Care | Skin to skin contact between infant and mother | Duration of hospitalization-expected average 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypothermia, Newborn, Hyperthermia, Kangaroo mother care