Hypothermia and the Effect of Ambient Temperature 2 (HEAT2)

The Impact of Ambient Cesarean Room Temperature on Neonatal Morbidity

Neonatal hypothermia is associated with increased risk of mortality as well as multiple morbidities. The prior HEAT study conducted at our institution showed a difference in neonatal hypothermia with a change in ambient operating room temperature. The investigator's objective is to determine if an increase in ambient operative room temperature decreases the rate of neonatal morbidity. Operating room temperature will be randomized to the current institutional standard of 20°C (67°F) or a temperature of 24°C (75°F), on a weekly basis for a period of 1.2 years.

Study Overview

• Status: Completed
• Conditions: Cesarean Section; Hypothermia; Neonatal Outcome
• Intervention / Treatment: Other: Change in ambient operating room temperature

Detailed Description

This is an open, prospective, randomized, single center trial that will address the primary research question: Does an increase in ambient operating room temperature result in a lower rate of composite neonatal morbidities? During the 1.2 year study period, the operating room temperatures on labor and delivery will be adjusted to either the current standard of care with ambient operating room temperature of 20°C (67°F), or the maximum temperature allowable per hospital policy in the current operating rooms, which is 24°C (75°F), as determined by cluster randomization. Composite neonatal morbidities will be recorded including hypoglycemia necessitating treatment; need for respiratory support within the first 24 hours; culture-proven sepsis; and mortality. Association of outcomes with the types of passive and active warming performed will include these morbidities stratified by gestational age as well as maternal outcomes. In addition, an electronic survey will be administered to the operating resident physicians to assess their experience with the study conditions.

• Study Type: Interventional
• Enrollment (Actual): 5221
• 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: Yes
• 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 unit during the study period.

Exclusion Criteria:

• Exclusion criteria include cases where a 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 and 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 operating room temperature of 67°F; These patients will have an operating room temperature of 67°F for cesarean delivery, the standard of care at our institution.
Active Comparator: Ambient operating room temperature of 75°F; Intervention: Ambient operating room temperature of 75°F for cesarean delivery, which is closer to World Health Organization recommendations.	Other: Change in ambient operating room temperature

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal Composite Morbidities	Need for respiratory support, Hypoglycemia necessitating treatment, Culture-proven sepsis; Mortality	Up to 24 hours following delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal Recovery Room Dwell Times after Cesarean		Up to 48h following delivery
Maternal Hypothermia	An oral temperature of less than 36.5C	Up to 24 hours after delivery

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Collaborators: Parkland Health and Hospital System

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: December 28, 2016
• First Submitted That Met QC Criteria: December 28, 2016
• First Posted (Estimate): January 2, 2017

Study Record Updates

• Last Update Posted (Actual): October 15, 2018
• Last Update Submitted That Met QC Criteria: October 10, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Temperature Changes; Hypothermia
• Other Study ID Numbers: STU 062016-040