临床试验/NCT04408534

NCT04408534Unknown不适用

Bilevel Noninvasive Ventilation in Infants With Bronchiolitis Presenting With Apnea

University Hospital, Grenoble0 个研究点目标入组 20 人开始时间: 2020年12月1日最近更新: 2020年5月29日

适应症

试验速览

阶段: 不适用
发起方
入组人数: 20
主要终点: Apnea

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

This physiological study aims to compare Bilevel Positive Airway Pressure and continuons positive airway pressure in infants with severe bronchiolitis presenting with apnea

详细描述

This study is a cross over randomized study which aims to compare the effect of 2 modes of noninvasive ventilation on the occurence of central apnea, as measured by electrical activity of the diaphragm

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Treatment
盲法: None

入排标准

年龄范围: 3 Days 至 6 Months（Child）
性别: All
接受健康志愿者: 否

入选标准

•Children born at gestational age > 36 weeks gestation
•Ventilated in Non Invasive Ventilation (NIV) for acute bronchiolitis (clinical criteria of the American Academy of Pediatrics)
•Having presented at least 1 apnea objectified by the parents or by a health care professional, as previously described (1), with one or more of the following characteristics: 1/Associated with bradycardia < 80 / min, 2/Associated with desaturation < 85% or 3/Duration more than 10 seconds
•Informed consent signed by at least one of the two parents + oral agreement from the second parent before the intervention of the study (2nd signature to be collected as soon as possible)

排除标准

•With chronic respiratory insufficiency requiring home ventilation (NIV or under long-term oxygen therapy, initiated at least 14 days before the start of the study)
•Ventilated in NIV for more than 48 hours before inclusion
•Hemodynamically significant cardiac disease, primary ENT or pulmonary pathology (malformative or genetic) or neuromuscular pathology
•Presenting a contraindication of a gastric tube (trauma or recent surgery concerning the cervical, pharyngeal or esophageal regions, severe coagulation disorders)
•Patient not affiliated to health care insurance

结局指标

主要结局

Apnea

时间窗: Up to 12 hours

Number of apnea

次要结局

未报告次要终点

研究者

发起方

University Hospital, Grenoble

申办方类型

Other

责任方

Sponsor

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