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临床试验/NCT07674953
NCT07674953招募中不适用

Oxygen Delivery in CPAP and Its Relationship With Regional Lung Ventilation in Preterm Infants

University of Arkansas2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2026年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
10
试验地点
2
主要终点
Inspired Oxygen

研究概览

简要总结

With this study, it is expected to learn more about preterm babies on breathing support with nasal continuous positive airway pressure (nCPAP). To gain more information on how much oxygen is actually delivered to the baby from the nCPAP machine.

详细描述

This study will tell more about a specific method of breathing support used frequently with preterm babies called nasal continuous positive airway pressure (nCPAP). It helps the baby breathe by providing air pressure and a certain amount of oxygen. It is very important for the baby's health to provide only as much oxygen as they need.

With this study, it is expected to learn if the amount of oxygen ordered by a doctor on the nCPAP machine changes when it reaches the baby's airway, and if the amount of oxygen changes depending on how much air pressure the doctor provides. The answers to these questions, are not known, because special measurements are required that are difficult to know while a baby is on nCPAP. This study will collect these special measurements

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Gestational age at birth must be less than 35 weeks of completed gestation as documented in the subject's initial history and physical
  • The infant must be stable while receiving nasal CPAP at any pressure level at the time of study
  • The infant must be receiving 22-40% at the time of the study

排除标准

  • Oxygen requirements greater than 40% at time of enrollment
  • currently receiving invasive ventilation or not requiring ventilatory support
  • Major congenital anomalies of the heart and/or lungs

结局指标

主要结局

Inspired Oxygen

时间窗: Sampling will occur at three separate points within a thirty minute time frame for each enrolled infant.

Percent of oxygen delivered to the back of the infant's mouth. This will be measured by placing a small plastic tube in the back of the infant's mouth and sampling the air while the infant is receiving several different pressure levels of CPAP.

次要结局

  • Lung Volume(Long volume will be continuously monitored throughout the 30 minute duration of the study for each enrolled infant.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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