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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
140
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.
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.
University Teaching Hospital
Lusaka, Zambia
Axillary temperature < 36.0 degrees Celsius
Temperature taken per axilla for one minute
Time frame: Time of birth to 1 hour
Axillary Temperature < 36.0 degrees Celsius
Temperature taken per axilla for one minute
Time frame: At discharge or 24 hours after birth (whichever is first)
Blood pressure
Measure of extremity blood pressure per cuff taken during nursery stay.
Time frame: Duration of hospitalization-expected average of 4 weeks
Blood glucose
Measure of blood glucose per laboratory value taken per heelstick
Time frame: Duration of hospitalization-expected average of 4 weeks
Seizure
Seizure activity diagnosed by medical doctor or nurse. No electroencephalogram will be done.
Time frame: 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
Time frame: Duration of hospitalization-expected average of 4 weeks
Sepsis
Culture proven or culture negative clinically treated course consistent with sepsis
Time frame: Duration of hospitalization-expected average of 4 weeks
Neonatal Intensive Care Unit Admission
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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.
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.
Any admission to NICU for need for higher level care
Time frame: Duration of hospitalization-expected average of 4 weeks
Death
Cardiorespiratory failure
Time frame: Duration of hospitalization-expected average of 4 weeks
Any Axillary Temperature < 36.0 degrees Celsius
Temperature taken per axilla for one minute
Time frame: Duration of hospitalization-expected average of 4 weeks
Duration of Kangaroo Mother Care
Skin to skin contact between infant and mother
Time frame: Duration of hospitalization-expected average 4 weeks