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临床试验/NCT04699708
NCT04699708Unknown不适用

Carbon -Di-Oxide Monitoring During Neonatal STAbilization at Delivery

South Tees Hospitals NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年5月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
试验地点
2
主要终点
Factors influencing carbon dioxide levels during preterm resuscitation

研究概览

简要总结

CO2 data, serving as a proxy marker for tidal volume, might enable titration of tidal volume/pressure thereby providing optimal ventilation during neonatal resuscitation.

Currently there is insufficient data on Co2 levels for preterm babies requiring resuscitation. This study involves monitoring of CO2 during preterm stabilisation.

详细描述

Measurement of exhaled CO2 in the delivery room is feasible, but clinical benefits of during neonatal transition have not been studied. Volume ventilation in the Neonatal unit has been shown to improve outcomes such BPD or death. Despite the proven benefits of volume ventilation in the neonatal unit volume guided resuscitation at birth remains an unproven and under-studied technique.

CO2 data, serving as a proxy marker for tidal volume, might enable titration of tidal volume/pressure thereby providing optimal ventilation during neonatal resuscitation. Currently there is insufficient data on Co2 levels for preterm babies requiring resuscitation. This data would help in finding out optimal resuscitation strategies (Pressures/volume, frequency of breaths) rather than providing the same for all infants throughout the process of resuscitation and would help us in better interpretation Co2 levels in the future resuscitation.

Investigators aim to study the impact of various clinical (Gestation, Birth weight, need for intubation/bag-mask ventilation) and resuscitative factors (use of inflation pressures, ventilation pressures, frequency of breaths, face mask ventilation, intubation) on CO2 during preterm stabilisation.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
23 Weeks 至 32 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • All preterm infants ≤ 32 weeks born at the study centres.
  • Needing resuscitative measures at the time of birth either in the form of face mask ventilation or intubation.

排除标准

  • Preterm infants below the threshold of viability as determined by the study team.
  • Major congenital or chromosomal abnormality (including congenital heart disease, Diaphragmatic hernia, congenital pulmonary airway malformations).
  • Severe oligohydramnios (Amniotic fluid index <5 or deep vertical pool≤2).

结局指标

主要结局

Factors influencing carbon dioxide levels during preterm resuscitation

时间窗: 1 year

To study the impact/correlation of various clinical factors (Gestation, Birth weight, need for intubation/bag-mask ventilation, surfactant administration, delayed cord clamping) and resuscitative factors (use of inflation pressures, ventilation pressures, frequency of breaths, face mask ventilation, intubation) on carbon dioxide measurements using MASIMO NOMOLINE capnography during preterm stabilisation.

次要结局

  • Correlation of Co2 with other parameters(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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