Hypothermia and the Effect of Ambient Temperature

Hypothermia Clinical Trial

— HEAT  

Official title:

The Impact of Ambient Operative Room Temperature on Neonatal and Maternal Hypothermia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02436382
• Other study ID #: STU 122014-046
• Status: Completed
• Phase: N/A
• First received: January 30, 2015
• Last updated: May 10, 2016
• Start date: February 2015
• Est. completion date: September 2015

Study information

• Verified date: May 2016
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: UT Southwestern Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 846
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypothermia

Intervention

Other:
• change in temperature
increase in ambient room temperature

Locations

Country	Name	City	State
United States	Parkland Memorial Hospital	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	neonatal hypoglycemia	hypoglycemia requiring treatment	up to 8 hours following delivery	No
Primary	neonatal hypothermia	a core temperature of less than 36.5C	up to 2 hours following delivery	No
Secondary	maternal hypothermia	an oral temperature of less than 36.5C	up to 10 hours following delivery	No