Hypothermia and the Effect of Ambient Temperature 2

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Impact of Ambient Cesarean Room Temperature on Neonatal Morbidity

Conditions
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Hypothermia, Neonatal Outcome, Cesarean Section

Intervention / Treatment
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* Other: Change in ambient operating room temperature


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Ambient operating room temperature of 67°F<br>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<br>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<br> <br> |

What is the study measuring?
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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 |