Hypothermia and the Effect of Ambient Temperature 2

Completed · Not applicable

Conditions studied: Hypothermia, Neonatal Outcome, Cesarean Section

In brief

Neonatal hypothermia is associated with increased risk of mortality as well as multiple morbidities. The prior HEAT study conducted at our institution showed a difference in neonatal hypothermia with a change in ambient operating room temperature. The investigator's objective is to determine if an increase in ambient operative room temperature decreases the rate of neonatal morbidity. Operating room temperature will be randomized to the current institutional standard of 20°C (67°F) or a temperature of 24°C (75°F), on a weekly basis for a period of 1.2 years.

Key facts

Study ID

NCT03008577

Run by

University of Texas Southwestern Medical Center

People needed

5221

Starts

2016-08-01

Expected to finish

2018-05-01

Last updated by the study team

2018-10-15

Who can join

Age: any. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• All pregnant women and their neonates undergoing cesarean delivery by the Parkland Hospital Obstetrics Service on the Labor and Delivery unit during the study period.

You may not qualify if…

• Exclusion criteria include cases where a 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 and resuscitative efforts are not performed ("comfort care only" provided), or a neonatal temperature is not available.

Where it is running

• Parkland Memorial Hospital — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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