A Multicenter Randomized Controlled Trial Comparing High Flow Nasal Cannula and NIPPV in Preterm Infants
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Rate of intubation within 7 days of starting the study treatment
研究概览
简要总结
The aim of this study is to compare the effectiveness of Heated Humidified High Flow Nasal Cannula (HHHFNC) versus Nasal Intermittent Positive Pressure Ventilation (NIPPV) in preventing intubation when used as primary respiratory support for Respiratory Distress Syndrome (RDS) or post extubation in preterm infants
详细描述
Patient population will include preterm infants born at 24 - 36+6 weeks of gestation who are candidates for non-invasive respiratory support post extubation or as primary respiratory support after birth. They will be will be randomized to 2 groups: Heated Humidified High Flow Nasal Cannula (HHHFNC) and Nasal Intermittent Positive Pressure Ventilation (NIPPV).
This will be a prospective unblinded randomized controlled study, designed as a non-inferiority trial.
Primary outcome: The primary outcome will be rate of treatment failure (need for intubation) within 7 days of starting the study treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants born at 24-27+6 weeks of gestation and up to 28 days of life who are extubated for the first time after birth or immediately after surfactant administration via (intubation-surfactant-extubation) INSURE or (minimally invasive surfactant therapy) MIST procedures.
- •Infants born at 28-36+6 weeks of gestation and up to 28 days of life who are candidates for non-invasive support either as a primary modality after birth or post extubation.
- •Signed parental informed consent by one of the parents
排除标准
- •Infants who are unlikely to survive the immediate postnatal period or who have significant congenital abnormalities
- •Presence of a pneumothorax prior to enrollment
- •Hemodynamic instability due to sepsis or hemorrhage
- •Inability to obtain parental consent
- •Shortage of suitable equipment
- •Infants who were intubated solely for surgery
结局指标
主要结局
Rate of intubation within 7 days of starting the study treatment
时间窗: one week
Failure of non invasive support by criteria of pH, blood carbon dioxide level, oxygen requirements or apneas
次要结局
未报告次要终点
研究者
Ayala Gover
principal investigator
Carmel Medical Center