Hypothermia and the Effect of Ambient Temperature

Not Applicable

Completed

• Conditions: Hypothermia
• Interventions: Other: change in temperature

• Registration Number: NCT02436382
• Lead Sponsor: University of Texas Southwestern Medical Center

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-01-30
• Study Start: 2015-02
• Study First Submitted QC: 2015-05-01
• Study First Posted: 2015-05-06
• Primary Completion: 2015-08
• Study Completion: 2015-09
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-10
• Last Update Posted: 2016-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 846

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ambient Temperature of 73F	change in temperature	These patient will have an operating room temperature of 73F for cesarean delivery, a temperature more consistent with WHO recommendations.

Primary Outcome Measures

Name	Time	Method
neonatal hypothermia	up to 2 hours following delivery	a core temperature of less than 36.5C

Secondary Outcome Measures

Name	Time	Method
maternal hypothermia	up to 10 hours following delivery	an oral temperature of less than 36.5C

Trial Locations

Locations (1)

Parkland Memorial Hospital; 🇺🇸 Dallas, Texas, United States