Hypothermia and the Effect of Ambient Temperature
Not Applicable
Completed
- Conditions
- Hypothermia
- Registration Number
- NCT02436382
- Lead Sponsor
- University of Texas Southwestern Medical Center
- Brief Summary
Neonatal hypothermia is associated with increased risk of mortality as well as multiple morbidities. The investigators objective is to determine if an increase in ambient operative room temperature decreases the rate of hypothermia. Operating room temperature will be randomized to the current institutional standard (67°F) or a temperature of 73°F on a weekly basis for a period of six months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 846
Inclusion Criteria
- All pregnant women and their neonates undergoing cesarean delivery by the Parkland Hospital Obstetrics Service on the Labor and Delivery "West" Unit (operating rooms 1, 2, 3, and 5) during the study period.
Exclusion Criteria
- Subjects will be excluded from the study if cesarean delivery is planned but a precipitous vaginal delivery occurs, intrauterine fetal demise has been diagnosed prior to start of surgery, the neonate is noted to have a major congenital anomaly, resuscitative efforts are not performed ("comfort care only" provided), or a neonatal temperature is not available.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method neonatal hypothermia up to 2 hours following delivery a core temperature of less than 36.5C
- Secondary Outcome Measures
Name Time Method maternal hypothermia up to 10 hours following delivery an oral temperature of less than 36.5C
Trial Locations
- Locations (1)
Parkland Memorial Hospital
🇺🇸Dallas, Texas, United States
Parkland Memorial Hospital🇺🇸Dallas, Texas, United States