Hypothermia and the Effect of Ambient Temperature

University of Texas Southwestern Medical Center846 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

846

Conditions

Hypothermia

Interventions

change in temperatureOTHER

increase in ambient room temperature

Eligibility

Sex: FEMALEHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Parkland Memorial Hospital

Dallas, Texas, United States

Outcomes

Primary Outcomes

neonatal hypothermia

a core temperature of less than 36.5C

Time frame: up to 2 hours following delivery

Secondary Outcomes

maternal hypothermia

an oral temperature of less than 36.5C

Time frame: up to 10 hours following delivery

Data from ClinicalTrials.gov

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