Hypothermia
Conditions
Keywords
Hypothermia, Newborn, Incubator, Plastic bag, Normothermia
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 V is comparing use of a plastic torso wrap to no plastic torso wrap in preterm/low birth weight infants following removal from their incubator to assist with temperature regulation.
Detailed description
Due to limited resources and numbers of incubators, hospitals in developing countries remove infants from incubators at lower weights than in developed countries, putting infants at increased risk for hypothermia. This study will compare the incidence of hypothermia during the 72 hours after incubator removal of infants randomized to receive standard incubator removal (control group) or standard incubator removal with a plastic bag covering their torsos and lower extremities (intervention group). The axillary temperature of each infant will be taken upon removal from the incubator, every subsequent 6-8 hours, and finally, at 72 hours as the bags are removed. Blood pressure, blood sugar, seizures, weight gain, hyperthermia, death, observation for respiratory distress, bronchopulmonary dysplasia, sepsis, intraventricular hemorrhage, periventricular leukomalacia, necrotizing enterocolitis, intestinal perforation, pulmonary hemorrhage room temperature and humidity, and length of time in an incubator will be recorded throughout their hospitalization for all infants. With an estimated hypothermia incidence of 30% and a hypothesized 20% absolute risk reduction (66% relative risk reduction), a sample size of 118 will be used to have a power of 80% and a confidence interval of 95%.
Interventions
PROCEDUREHypothermia prevention with plastic bag
Upon removal from the incubator, infant will be placed into a plastic bag 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. The infant will be wrapped in a blanket and receive a cloth hat. The bag will be changed when soiled and the infant will remain in the bag for 72 hours or until discharge, whichever comes first. The infant's temperature will be monitored for 72 hours or until discharge, whichever comes first.
PROCEDUREHypothermia prevention without plastic bag
Upon removal from incubator, the infant will be wrapped in a blanket and receive a cloth hat, according to standard bundling practices. The infant's temperature will be monitored for 72 hours or until discharge, whichever comes first.
Sponsors
Children's of 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 72 Hours
Healthy volunteers
No
Inclusion criteria
* Infant admitted to the NICU * Current weight less than 2,000g * Being removed from incubator
Exclusion criteria
* Abdominal wall defect or myelomeningocele * Major congenital anomalies * Blistering skin disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Axillary temperature 36.5-37.5 degrees Celsius | 1-72 hours | Temperature taken per axilla for one minute |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure | Up to 4 weeks | Measure of extremity blood pressure per cuff taken during nursery stay |
| Blood glucose | Up to 4 weeks | Measure of blood glucose per laboratory value taken per heel stick |
| Weight gain | Up to 4 weeks | Infant will be weighed daily and rates of weight gain will be calculated |
| Respiratory Distress Syndrome (RDS) | Up to 4 weeks | Documentation of increased work of breathing, retractions, and a need for oxygen, intubation, or surfactant |
| Bronchopulmonary Dysplasia (BPD) | 28 days after birth | Oxygen requirement at 28 days of life |
| 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 doctor or nurse. No electoencephalogram will be done. |
| 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. |
| Pulmonary hemorrhage | Up to 4 weeks | Blood seen in the endotracheal tube and treated by physician |
| Death | Up to 4 weeks | Cardiorespiratory failure |
| Hyperthermia | Up to 4 weeks | Axillary temperature \> 38 degrees Celsius per temperature taken per axilla for 1 minute |
| Length of time in incubator | Up to 4 weeks | Documentation of length of time spent in incubator and number of times placed in incubator |
| Room temperature and humidity | 1-72 hours | A recording of the room temperature and humidity will be obtained with each axillary temperature measurement |
| Incubator temperature and humidity | 1 hour | A recording of the air temperature and humidity with the incubator will be obtained with each axillary temperature measurement |
| Major brain injury | Up to 4 weeks | Intracranial hemorrhage grade 3-4 or periventricular leukomalacia documented on cranial ultrasound |
Countries
Zambia
Outcome results
None listed