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临床试验/NCT03008577
NCT03008577已完成不适用

The Impact of Ambient Cesarean Room Temperature on Neonatal Morbidity

University of Texas Southwestern Medical Center2 个研究点 分布在 1 个国家目标入组 5,221 人开始时间: 2016年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
5,221
试验地点
2
主要终点
Neonatal Composite Morbidities

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Change in ambient operating room temperature (Other)

结局指标

主要结局

Neonatal Composite Morbidities

时间窗: Up to 24 hours following delivery

Need for respiratory support, Hypoglycemia necessitating treatment, Culture-proven sepsis; Mortality

次要结局

  • Maternal Hypothermia(Up to 24 hours after delivery)
  • Maternal Recovery Room Dwell Times after Cesarean(Up to 48h following delivery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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