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Hypothermia and the Effect of Ambient Temperature (HEAT)

Primary Purpose

Hypothermia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
change in temperature
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypothermia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts 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.

Sites / Locations

  • Parkland Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Ambient Temperature of 67F

Ambient Temperature of 73F

Arm Description

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

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

Outcomes

Primary Outcome Measures

neonatal hypothermia
a core temperature of less than 36.5C

Secondary Outcome Measures

maternal hypothermia
an oral temperature of less than 36.5C

Full Information

First Posted
January 30, 2015
Last Updated
May 10, 2016
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02436382
Brief Title
Hypothermia and the Effect of Ambient Temperature
Acronym
HEAT
Official Title
The Impact of Ambient Operative Room Temperature on Neonatal and Maternal Hypothermia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
846 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ambient Temperature of 67F
Arm Type
No Intervention
Arm Description
These patients will have an operating room temperature of 67F for cesarean delivery, the standard of care at our institution.
Arm Title
Ambient Temperature of 73F
Arm Type
Active Comparator
Arm Description
These patient will have an operating room temperature of 73F for cesarean delivery, a temperature more consistent with WHO recommendations.
Intervention Type
Other
Intervention Name(s)
change in temperature
Intervention Description
increase in ambient room temperature
Primary Outcome Measure Information:
Title
neonatal hypothermia
Description
a core temperature of less than 36.5C
Time Frame
up to 2 hours following delivery
Secondary Outcome Measure Information:
Title
maternal hypothermia
Description
an oral temperature of less than 36.5C
Time Frame
up to 10 hours following delivery
Other Pre-specified Outcome Measures:
Title
neonatal hypoglycemia
Description
hypoglycemia requiring treatment
Time Frame
up to 8 hours following delivery

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Parkland Memorial Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States

12. IPD Sharing Statement

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Hypothermia and the Effect of Ambient Temperature

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