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| Name | Class |
|---|---|
| Parkland Health and Hospital System | OTHER |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ambient operating room temperature of 67°F | No Intervention | These patients will have an operating room temperature of 67°F for cesarean delivery, the standard of care at our institution. | |
| Ambient operating room temperature of 75°F | Active Comparator | Intervention: Ambient operating room temperature of 75°F for cesarean delivery, which is closer to World Health Organization recommendations. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Change in ambient operating room temperature | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neonatal Composite Morbidities | Need for respiratory support, Hypoglycemia necessitating treatment, Culture-proven sepsis; Mortality | Up to 24 hours following delivery |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parkland Memorial Hospital | Dallas | Texas | 75235 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36918157 | Derived | Ambia AM, Duryea EL, Wyckoff MH, Tao W, McIntire DD, Seasely AR, Moussa M, Leveno KJ. A Randomized Trial of the Effects of Ambient Operating Room Temperature on Neonatal Morbidity. Am J Perinatol. 2024 May;41(S 01):e1553-e1559. doi: 10.1055/a-2053-7242. Epub 2023 Mar 14. |
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| ID | Term |
|---|---|
| D007035 | Hypothermia |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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