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临床试验/NCT05036161
NCT05036161Unknown不适用

ROX Index and ROX Vector to Predict Nasal High Flow / Continuous Positive Airway Pressure Failure in Neonates

Erebouni Medical Center3 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年9月6日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
3
主要终点
Number of participants requiring escalation of treatment

研究概览

简要总结

Nasal continuous positive airway pressure (CPAP) and Nasal High Flow (NHF) therapy are two primary therapies for the treatment of respiratory distress in newborns. However, a considerable number of infants, who are initially treated with CPAP and NHF, will develop worsening respiratory failure and eventually require intubation for mechanical ventilation and the administration of surfactant. Infants who fail noninvasive respiratory therapy may suffer the consequences of delayed intubation, surfactant administration and other adverse outcomes. The most challenging decisions in the management of respiratory distress after birth is to decide when to move from a noninvasive respiratory support to invasive mechanical ventilation and give surfactant to decrease pulmonary damage and improve outcomes. There are no clinically adequate predictors of early CPAP failure at the time of admission to the neonatal intensive care unit. Many measurements have been investigated for their ability to predict CPAP failure in infants such as fraction of inspired oxygen (FiO2), partial pressure of oxygen (PaO2), PaO2/FiO2 and the stable micro bubble test as soon as possible after birth. Roca and colleagues first established the ROX index to predict the success of NHF therapy in adults with pneumonia. The ROX index combines three common measurements: FiO2, peripheral oxygen saturation (SpO2) and respiratory rate. Combining the ROX values with the change in the respiratory rate and FiO2 can indicate whether escalation is required. It was proposed that XY plot of the key components of ROX may show the direction of changes in vector form.

The investigators hypothesized that the ROX index and ROX vector can be used for predicting the failure of CPAP and NHF in neonates.

详细描述

The objective is to explore the usefulness of ROX index to predict treatment failure of NHF and CPAP therapies in neonates.

The primary outcome is treatment failure within 72 h after start of the therapy with NHF or CPAP

Treatment failure criteria is reached once an infant is receiving maximal therapy for their treatment (NHF 8 L/min) or CPAP 7 cm H2O plus at least one of:

  1. Sustained increase in oxygen requirement ≥50% to maintain peripheral oxygen saturation (SpO2) 90%-94%.
  2. Any infant requiring urgent intubation and the subsequent mechanical ventilation, as determined by the physician.

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
— 至 24 Hours(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Number of participants requiring escalation of treatment

时间窗: 72 hours

Treatment failure criteria is reached once an infant is receiving maximal therapy for their treatment (NHF 8 L/min) or CPAP 7 cm H2O plus at least one of: 1. Sustained increase in oxygen requirement above ≥50% to maintain peripheral oxygen saturation (SpO2) 90%-94%. 2. Any infant requiring urgent intubation and the subsequent mechanical ventilation, as determined by the physician.

次要结局

  • Number of participants with Necrotizing enterocolitis stage II-III(Monitored for the entire stay in hospital, until discharge, up to 6 months)
  • Number of participants with Bronchopulmonary dysplasia(through study completion, up to 6 months)
  • Number of participants with Cystic Periventricular Leukomalacia(Monitored for the entire stay in hospital, until discharge, up to 6 months)
  • Number of participants with ROP needing laser treatment(Monitored for the entire stay in hospital, until discharge, up to 6 months)
  • Number of participants with Intra-ventricular hemorrhage(Monitored for the entire stay in hospital, until discharge, up to 6 months)
  • total number of days on O2 / noninvasive ventilation(Monitored for the entire stay in hospital, until discharge, up to 6 months)
  • Number of participants with PDA needed surgical treatment(Monitored for the entire stay in hospital, until discharge, up to 6 months)
  • Number of participants requiring blood transfusion(Monitored for the entire stay in hospital, until discharge, up to 6 months)
  • Total number days in the hospital(Monitored for the entire stay in hospital, until discharge, up to 6 months)
  • Number of participants with death(Monitored for the entire stay in hospital, until discharge, up to 6 months)
  • Number of participants with pneumothorax(Monitored for the entire stay in hospital, until discharge, up to 6 months)

研究者

发起方
Erebouni Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pavel Mazmanyan

Professor

Erebouni Medical Center

研究点 (3)

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