NCT06683677尚未招募不适用
High Flow Nasal Cannula is Appropriate Alternative for Stabilization of Extremely Premature Infants: a Prospective Observational Study
Charles University, Czech Republic2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年12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
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Positive pressure ventilation after delivery
研究概览
简要总结
A prospective observational study evaluates the safety and efficacy of using High-Flow Nasal Cannula to stabilize extremely preterm infants immediately after birth. Following placental transfusion, high flow nasal cannula at 6-8 l/min is administered along with intermittent tactile stimulation. Criteria for switching to other interventions like continuous positive airway pressure or positive pressure ventilation are set for cases of persistent bradycardia or low Saturation of oxygen (SpO2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 0 Minutes 至 2 Minutes（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants born between 25+0 and 27+6 gestational weeks
- •Weight above 500 grams
排除标准
- •Previable rupture of membranes,
- •Congenital malformations previable
- •Acute intrauterine hypoxia.
结局指标
主要结局
Positive pressure ventilation after delivery
时间窗: 10 minutes
The number of infants who required positive pressure ventilation (PPV) in the first ten minutes after delivery.
次要结局
- SpO₂ > 80% in five minutes after delivery(5 minutes)
- SpO₂ > 90% ten minutes after delivery(10 minutes)
研究者
Jonáš Klára
Principal Investigator
Charles University, Czech Republic
研究点 (2)
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