Hypothermia and the Effect of Ambient Temperature (HEAT)

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

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 Overview

• Status: Completed
• Conditions: Hypothermia
• Intervention / Treatment: Other: change in temperature

• Study Type: Interventional
• Enrollment (Actual): 846
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75235
      • Parkland Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Ambient Temperature of 67F; These patients will have an operating room temperature of 67F for cesarean delivery, the standard of care at our institution.
Active Comparator: Ambient Temperature of 73F; These patient will have an operating room temperature of 73F for cesarean delivery, a temperature more consistent with WHO recommendations.	Other: change in temperature; increase in ambient room temperature

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
neonatal hypothermia	a core temperature of less than 36.5C	up to 2 hours following delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
maternal hypothermia	an oral temperature of less than 36.5C	up to 10 hours following delivery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
neonatal hypoglycemia	hypoglycemia requiring treatment	up to 8 hours following delivery

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: January 30, 2015
• First Submitted That Met QC Criteria: May 1, 2015
• First Posted (Estimate): May 6, 2015

Study Record Updates

• Last Update Posted (Estimate): May 11, 2016
• Last Update Submitted That Met QC Criteria: May 10, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Temperature Changes; Hypothermia
• Other Study ID Numbers: STU 122014-046