Hypothermia, Newborn
Conditions
Keywords
Hypothermia, Newborn, Resuscitation, Plastic bag
Brief summary
The overall hypothesis is that placing infants 1000-2500 grams in plastic bags when compared to routine care will reduce the risk of hypothermia (\< 36.5 degrees C) without increasing hyperthermia (\> 37.5 degrees C).
Detailed description
Prevention After consent, infants with estimated gestational age between 26-36.6 weeks or with expected birth weight 1000-2500 grams will be randomized to resuscitation per standard protocol or to resuscitation per standard protocol and plastic bag. The intervention group will be placed into a plastic bag covering the body and back and top of head (excluding face) prior to drying the body's surface. Resuscitation efforts continue per standard of care. The infant will remain in the bag through the admission process until his/her axillary temp is in the range of 36.5- 37.5 degrees Celsius. At this time, the bag will be discontinued and discarded. Standard temperature control will be continued per nursery standard. Skin-to-skin contact between mother and baby is not excluded; however, the infant will remain in the plastic bag. Infant's axillary temperature will be measured per nursery standard after discontinuation of plastic bag. The control group will receive standard of care thermoregulation. Secondary measures (i.e. blood pressures, glucose levels, weight gain, observation for respiratory distress syndrome, bronchopulmonary dysplasia, pneumothorax, sepsis, seizures, intraventricular hemorrhage, necrotizing enterocolitis, pulmonary hemorrhage, and death) will be recorded in both groups.
Interventions
PROCEDUREResuscitation and post resuscitation care with plastic bag
Infant will be resuscitated and placed in a plastic bag up to his/her neck and around the back of his head (not covering the face) in the delivery room and taken to the nursery. The infant will remain in the plastic bag until first axillary temperature remains stable at 36.5-37.5 degrees Celsius. Expected length of time approximately one hour.
PROCEDUREResuscitation- no plastic bag for temperature regulation
Infant will be resuscitated in the delivery room and taken to the nursery. The infant will be observed per unit standard until first axillary temperature remains stable at 36.5-37.5 degrees Celsius. Expected length of time approximately one hour.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Estimated gestational age 26-36.6 weeks or expected birth weight 1000-2500 grams. * Delivery in the hospital.
Exclusion criteria
* Abdominal wall defect or myelomeningocele. * Major congenital anomaly. * Blistering skin disorder.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Axillary temperature 36.5-37.5 degrees Celsius | 1-4 hours | Temperature taken per axilla for 1 minute |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Weight gain | Duration of hospitalization-expected average of 4 weeks | Infant will be weighed daily and rates of weight gain will be measured. |
| Respiratory Distress Syndrome (RDS) | Duration of hospitalization-expected average of 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 |
| Blood pressure | Duration of hospitalization-expected average of 4 weeks | Measure of extremity blood pressure per cuff taken during nursery stay. |
| Sepsis | Duration of hospitalization-expected average of 4 weeks | Culture proven or culture negative clinically treated course consistent with sepsis. |
| Major brain injury | Duration of hospitalization-expected average of 4 weeks | Intracranial hemorrhage Grade 3-4 or periventricular leukomalacia documented on cranial ultrasound |
| Necrotizing enterocolitis or intestinal perforation | Duration of hospitalization-expected average of 4 weeks | Documentation of pneumatosis or intestinal perforation on x ray or treatment course for clinical necrotizing enterocolitis per Bell's stage greater than one. |
| Pulmonary hemorrhage | Duration of hospitalization-expected average of 4 weeks | Blood seen in the endotracheal tube and treated by physician. |
| Death | Duration of hospitalization-expected average of 4 weeks | Cardiorespiratory failure |
| Pneumothorax | Duration of hospitalization-expected average of 4 weeks | Either chest radiograph documentation or clinical deterioration consistent with air leak |
Countries
Zambia
Outcome results
None listed