Hypothermia, Immature Newborn
Conditions
Keywords
Hypothermia, Low birth Weight, Newborn, Resuscitation, Plastic bag
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 I is for preterm/low birth weight infant with or without plastic head cover used during resuscitation.
Detailed description
This study will compare the incidence of hypothermia during the first hour after birth in preterm/low birth weight infants randomized to receive WHO thermoregulation care and a plastic bag (without drying) covering the torso and lower extremities (control group) or WHO thermoregulation care and a plastic bag (without drying) covering the torso, upper and lower extremities, and a portion of their head (intervention group). The axillary temperature of each infant will be taken initially within 15 minutes of birth and later at 1 hour after birth as the infant is removed from the plastic bag. Seizures, hyperthermia, room temperature, and death will be recorded throughout the hospitalization for all infants. With an estimated baseline hypothermia rate of 41% and a 21% absolute risk reduction (51% relative risk reduction), a sample size of 182 will be used to have a power of 80% and a confidence interval of 95%.
Interventions
PROCEDUREResuscitation-torso plastic bag
Infant's extremities and torso will be placed in a plastic bag during resuscitation after birth and maintained for 1 hour after birth.
PROCEDUREResuscitation-partial-head plastic bag
Infant's torso, extremities, and portion of the head (face will be exposed) will be placed in a plastic bag during resuscitation after birth and maintained for 1 hour after birth.
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 Minutes to 1 Hours
Healthy volunteers
No
Inclusion criteria
* Estimated gestational age 29-36 6/7weeks or birth weight 1,400-2500g * Delivery in the hospital
Exclusion criteria
* Infant admitted to the NICU * Birth weight less than 1,400g * Abdominal wall defect or myelomeningocele * Major congenital anomalies * Blistering skin disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Axillary temperature < 36.5 degrees Celsius | 1-72 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 will be classified 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 doctor 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 one. |
Countries
Zambia
Outcome results
None listed