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临床试验/NCT03145142
NCT03145142进行中(未招募)不适用

PREMOD2 NIRS Substudy - A Randomized Trial of Cerebral Oxygen Saturation in Infants Randomized to Umbilical Cord Milking or Delayed Cord Clamping

Sharp HealthCare7 个研究点 分布在 4 个国家目标入组 121 人开始时间: 2017年6月6日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (7)

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