Hypothermia
Conditions
Keywords
Hypothermia, Low birth weight, Newborn, Plastic bag, Thermoregulation
Brief summary
The overall hypothesis is that plastic bags used in combination with WHO thermoregulation care will reduce the incidence of hypothermia in preterm/low birth weight and full term infants when compared to routine WHO thermoregulation care alone. Part II is for preterm/low birth weight infant with or without plastic head cover used from 1 hour after birth until discharge or 24 hours after birth to assist with temperature regulation.
Detailed description
Due to limited resources, hospitals in the developing world struggle to provide sufficient incubators and to maintain climate-controlled nurseries. Therefore, premature low birth weight infants continue to be at an increased risk of hypothermia throughout their hospitalizations. This study will compare the incidence of hypothermia in preterm/low birth weight infants randomized to receive WHO thermoregulation care (control groups) or WHO thermoregulation care and a plastic bag covering their torsos and lower extremities (intervention group) starting at one hour after birth and continued to discharge or 24 hours after birth, whichever occurs first. The axillary temperature of each infant will be taken one hour after birth, every subsequent 3-4 hours, and at discharge or 24 hours after birth when infants will be removed from the plastic bags. Seizures, hyperthermia, room temperature, and death will be recorded throughout the hospitalization for all infants. With an estimated baseline hypothermia rate of 50% and a hypothesized 20% absolute risk reduction (40% relative risk reduction), a sample size of 182 will be used to have a power of 80% and a confidence interval of 95%.
Interventions
PROCEDUREThermoregulation-standard care
Standard care without plastic bag. One hour after birth, a blanket will be wrapped around the infant and he/she will receive a wool hat, according to standard practices. The infant's axillary temperature will be monitored for 24 hours or until discharge, whichever comes first.
PROCEDUREThermoregulation with plastic bag
One hour after birth, the infant will be placed into a plastic bag up to his/her axillae, and the bag will be folded and taped to itself to prevent it from covering the infant's nose or mouth. A blanket will be wrapped around the infant, and he/she will receive a wool hat. The infant will remain in the bag, which will be changed when soiled, for 24 hours or until discharge, whichever occurs first.
Sponsors
Children's Health System, Alabama
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Hours to 120 Days
Healthy volunteers
No
Inclusion criteria
* Estimated gestational age 29-36 6/7 weeks or birth weight 1400-2500g * Delivery in the hospital
Exclusion criteria
* Infant admitted to the NICU * Birth weight less than 1400 gms * Abdominal wall defect or myelomeningocele * Major congenital anomalies * Blistering skin disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Axillary temperature < 36.5 degrees Celsius | Discharge or 24 hours after birth | Temperature taken per axilla at one hour after birth. Temperatures 36.0-36.4 will be classified as mild hypothermia, 32.0-35.9 will be classified as moderate hypothermia, and \<32.0 as severe hypothermia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory Distress Syndrome (RDS) | Up to 4 weeks | Documentation of increased work of breathing, retractions, and a need for oxygen, intubation, or surfactant |
| Pneumothorax | Up to 4 weeks | Either chest radiograph documentation or clinical deterioration consistent with air leak |
| Sepsis | Up to 4 weeks | Culture proven or culture negative clinically treated course consistent with sepsis |
| Seizure | Up to 4 weeks | Seizure activity diagnosed by medical director or nurse. No electroencephalogram will be done. |
| Death | Up to 4 weeks | Cardiorespiratory failure |
| Hyperthermia | Up to 4 weeks | Axillary temperature \> 38 degrees Celsius per temperature taken per axilla for one minute |
| Temperature and humidity | 1-72 hours after birth | A recording of the room temperature and humidity will be obtained with each axillary temperature measurement |
| Necrotizing enterocolitis or intestinal perforation | Up to 4 weeks | Documentation of pneumatosis or intestinal perforation on x-ray or treatment course for clinical necrotizing enterocolitis per Bell's Classification stage greater than 1. |
Countries
Zambia
Outcome results
None listed