Hypothermia and the Effect of Ambient Temperature 2

Not Applicable

Completed

• Conditions: Neonatal Outcome; Cesarean Section; Hypothermia
• Interventions: Other: Change in ambient operating room temperature

• Registration Number: NCT03008577
• 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 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.

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 Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-12-28
• Study First Submitted QC: 2016-12-28
• Study First Posted: 2017-01-02
• Primary Completion: 2018-05
• Study Completion: 2018-05
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-10
• Last Update Posted: 2018-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 5221

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ambient operating room temperature of 75°F	Change in ambient operating room temperature	Intervention: Ambient operating room temperature of 75°F for cesarean delivery, which is closer to World Health Organization recommendations.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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