Hypothermia and the Effect of Ambient Temperature 2

Cesarean Section Clinical Trial

— HEAT2  

Official title:

The Impact of Ambient Cesarean Room Temperature on Neonatal Morbidity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03008577
• Other study ID #: STU 062016-040
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: May 2018

Study information

• Verified date: October 2018
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5221
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cesarean Section
• Hypothermia
• Neonatal Outcome

Intervention

Other:
• Change in ambient operating room temperature

Locations

Country	Name	City	State
United States	Parkland Memorial Hospital	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	Parkland Health & Hospital System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neonatal Composite Morbidities	Need for respiratory support, Hypoglycemia necessitating treatment, Culture-proven sepsis; Mortality	Up to 24 hours following delivery
Secondary	Maternal Recovery Room Dwell Times after Cesarean		Up to 48h following delivery
Secondary	Maternal Hypothermia	An oral temperature of less than 36.5C	Up to 24 hours after delivery