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临床试验/NCT05961670
NCT05961670尚未招募不适用

Application of Lung Near-Infrared Spectroscopy (NIRS) During Invasive and Non-Invasive Ventilation and Pre- and Post-Surfactant Administration in Preterm Infants

Keck School of Medicine of USC1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
试验地点
1
主要终点
rpSO2 before and after surfactant therapy

研究概览

简要总结

Premature infants are more likely to develop hypoxemia after birth often requiring invasive and Non-Invasive Mechanical ventilation and surfactant therapy to improve alveolar gas exchange and oxygen transport. Near-infrared spectroscopy (NIRS) has been used to detect pulmonary regional oxygen saturation (rpSO 2 ) as well as cerebral regional oxygen saturation (rcSO2 ) and evaluate the oxygenation state of the lung and brain. This is a prospective observational study to evaluate utility of rpSO2 and compare it with rcSO2 in preterm infants born between 23-32 weeks of gestation receiving noninvasive ventilation and surfactant treatment. Enrolled patients will be continuously studied with placement of NIRS monitor using cerebral sensor (INVOS™) for 6 hrs and 15 min before and after surfactant administration. Pulmonary regional oxygen saturation (rpSO2) with a sampling interval of 6 s will be followed for 6hrs.

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
1 Hour 至 24 Hours(Child)
性别
All
接受健康志愿者

入选标准

  • Infants born between 23-32 weeks of gestation admitted to the Neonatal Intensive Care Unit with respiratory distress receiving non-invasive ventilation and requiring Surfactant Replacement Therapy.

排除标准

  • Neonates with no need for respiratory support/Surfactant. Neonates with congenital malformations.

结局指标

主要结局

rpSO2 before and after surfactant therapy

时间窗: 6 hours

brain and lung rpSO2 will be compared before and after surfactant administration

次要结局

  • variations on rpSO2 and rcSO2 during changes in ventilation modes(6 hours)
  • correlation between rpSO2L and SpO2/FiO2 ratio, a/APO2, and O.I(6 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Manoj Biniwale

Associate Professor of Pediatrics

Keck School of Medicine of USC

研究点 (1)

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