HEAT: Hypothermia and the Effect of Ambient Temperature

Sponsor

University of Texas Southwestern Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT02436382

Collaborator

(none)

846

Enrollment

Location

Arms

Duration (Months)

121.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hypothermia	Other: change in temperature	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

846 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Feb 1, 2015

Actual Primary Completion Date :

Aug 1, 2015

Actual Study Completion Date :

Sep 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

neonatal hypothermia [up to 2 hours following delivery]
a core temperature of less than 36.5C

Secondary Outcome Measures

maternal hypothermia [up to 10 hours following delivery]
an oral temperature of less than 36.5C

Other Outcome Measures

neonatal hypoglycemia [up to 8 hours following delivery]
hypoglycemia requiring treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Parkland Memorial Hospital	Dallas	Texas	United States	75235

Sponsors and Collaborators

University of Texas Southwestern Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Elaine Duryea, Fellow Physician, University of Texas Southwestern Medical Center

ClinicalTrials.gov Identifier:

NCT02436382

Other Study ID Numbers:

STU 122014-046

First Posted:

May 6, 2015

Last Update Posted:

May 11, 2016

Last Verified:

May 1, 2016

Additional relevant MeSH terms:

Hypothermia

Study Results

No Results Posted as of May 11, 2016