Hypothermia, Newborn
Conditions
Keywords
Hypothermia, Newborn, Hyperthermia, Kangaroo mother care
Brief summary
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
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.
Interventions
OTHERContinuous Kangaroo Mother Care to 1 hour after birth
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.
OTHERStandard Kangaroo Mother Care to 1 hour after birth
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.
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.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Minutes to 8 Weeks
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Axillary temperature < 36.0 degrees Celsius | Time of birth to 1 hour | Temperature taken per axilla for one minute |
| Axillary Temperature < 36.0 degrees Celsius | At discharge or 24 hours after birth (whichever is first) | Temperature taken per axilla for one minute |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure | Duration of hospitalization-expected average of 4 weeks | Measure of extremity blood pressure per cuff taken during nursery stay. |
| Blood glucose | Duration of hospitalization-expected average of 4 weeks | Measure of blood glucose per laboratory value taken per heelstick |
| Seizure | Duration of hospitalization-expected average of 4 weeks | Seizure activity diagnosed by medical doctor or nurse. No electroencephalogram will be done. |
| Respiratory Distress Syndrome (RDS) | Duration of hospitalization-expected average of 4 weeks | Documentation of increased work of breathing, retractions, and need for oxygen, intubation or surfactant |
| Sepsis | Duration of hospitalization-expected average of 4 weeks | Culture proven or culture negative clinically treated course consistent with sepsis |
| Neonatal Intensive Care Unit Admission | Duration of hospitalization-expected average of 4 weeks | Any admission to NICU for need for higher level care |
| Death | Duration of hospitalization-expected average of 4 weeks | Cardiorespiratory failure |
| Any Axillary Temperature < 36.0 degrees Celsius | Duration of hospitalization-expected average of 4 weeks | Temperature taken per axilla for one minute |
| Duration of Kangaroo Mother Care | Duration of hospitalization-expected average 4 weeks | Skin to skin contact between infant and mother |
Countries
Zambia
Outcome results
None listed