Hypothermia and the Effect of Ambient Temperature (HEAT)

The University of Texas System (UT)

Status: Completed

Conditions: Hypothermia

Treatments: Other: change in temperature

Study type: Interventional

Funder types: Other

Identifiers

NCT02436382

STU 122014-046

Details and patient eligibility

About

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.

Enrollment: 846 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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846 participants in 2 patient groups

Ambient Temperature of 67F

No Intervention group

Description:

These patients will have an operating room temperature of 67F for cesarean delivery, the standard of care at our institution.

Ambient Temperature of 73F

Active Comparator group

Description:

These patient will have an operating room temperature of 73F for cesarean delivery, a temperature more consistent with WHO recommendations.

Treatment:

Other: change in temperature