The Impact of Ambient Operative Room Temperature on Neonatal and Maternal Hypothermia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 846
- 试验地点
- 1
- 主要终点
- neonatal hypothermia
研究概览
简要总结
Neonatal hypothermia is associated with increased risk of mortality as well as multiple morbidities. The investigators objective is to determine if an increase in ambient operative room temperature decreases the rate of hypothermia. Operating room temperature will be randomized to the current institutional standard (67°F) or a temperature of 73°F on a weekly basis for a period of six months.
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
- 是
入选标准
- •All pregnant women and their neonates undergoing cesarean delivery by the Parkland Hospital Obstetrics Service on the Labor and Delivery "West" Unit (operating rooms 1, 2, 3, and 5) during the study period.
排除标准
- •Subjects will be excluded from the study if 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, resuscitative efforts are not performed ("comfort care only" provided), or a neonatal temperature is not available.
研究组 & 干预措施
Ambient Temperature of 67F
These patients will have an operating room temperature of 67F for cesarean delivery, the standard of care at our institution.
Ambient Temperature of 73F
These patient will have an operating room temperature of 73F for cesarean delivery, a temperature more consistent with WHO recommendations.
干预措施: change in temperature (Other)
结局指标
主要结局
neonatal hypothermia
时间窗: up to 2 hours following delivery
a core temperature of less than 36.5C
次要结局
- maternal hypothermia(up to 10 hours following delivery)
研究者
Elaine Duryea
Fellow Physician
University of Texas Southwestern Medical Center