PREMOD2 NIRS Substudy - A Randomized Trial of Cerebral Oxygen Saturation in Infants Randomized to Umbilical Cord Milking or Delayed Cord Clamping
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 121
- 试验地点
- 7
- 主要终点
- StO2 - 10M
研究概览
简要总结
Early hemodynamic effects (within 3 hours of life) of Delayed Cord Clamping compared to Umbilical Cord Milking are still unknown. Four sites experienced in the use of NIRS and who have appropriate data collection equipment in the delivery room (Alberta, Ulm, Cork and San Diego) will obtain and report the physiological changes with UCM and DCC from birth until 24 hours of life. This data will yield the largest available sample of continuously recorded heart rate, cerebral tissue oxygenation, peripheral oxygen saturation, airway pressure, and administered FiO2 to delineate the short term responses to two methods of placental transfusion. In our initial trial we demonstrated increased blood pressure from 3-15 HOL with UCM compared to DCC in premature newborns <32 weeks, but did not show any differences in cerebral oxygenation.
详细描述
This substudy will include 400 infants <28 weeks GA enrolled in the PREMOD2 trial. Once the newborn has been delivered, received the intervention (UCM or DCC), and been placed on the resuscitation bed a NIRS sensor and a pulse oximeter will be placed within 60 seconds. While arterial saturation and heart rate data will be available to the clinical team, data from NIRS will be blinded. Data on all study infants will be recorded for at least the first 10 minutes in the delivery room, and then for 24 hours in the NICU. Heart rate, oxygen saturations, and cerebral oxygenation, will be downloaded as per each site's practice for neonatal resuscitation.
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
- 年龄范围
- 23 Weeks 至 28 Weeks(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •23 weeks 0 days to 27 weeks 6 days.
- •Enrolled in PREMOD2 trial.
排除标准
- •NIRS Device not available
- •Research Personnel not available
结局指标
主要结局
StO2 - 10M
时间窗: 1st 10 minutes of life
Cerebral Tissue Oxygen Saturation in the Delivery Room
次要结局
- HR 24H(1st 24 hours of life)
- StO2 - 24H(1st 24 hours of life)
- HR - 10M(1st 10 minutes of life)
- Blood Pressure NICU(2st 24 hours of life)
