NCT03989960Unknown不适用
Application of Modified Intubation-surfactant-extubation (InSurE) Technique in Preterm Neonates With Respiratory Distress Syndrome
The First Affiliated Hospital with Nanjing Medical University2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2018年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- the duration of oxygen therapy
研究概览
简要总结
This study evaluates the less invasive surfactant administration (LISA) combined with synchronized nasal intermittent positive pressure ventilation (SNIPPV) technique in the treatment of respiratory distress syndrome (RDS) of preterm neonates. The modified InSurE group will receive "LISA + SNIPPV" technique, while the traditional InSurE group will receive the intubation, surfactant, extubation and CPAP technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •premature infants with birth weight < 2500g and gestational age < 36+6 weeks;
- •High-risk premature infants with early symptoms of RDS or infants who are diagnosed clinically RDS.
- •the participating hospital obtained the consent of the Ethics Committee.
- •parental informed consents were obtained.
排除标准
- •severe congenital malformations.
- •severe cyanotic congenital heart disease (such as transposition of great artery, tetralogy of Fallot, etc.) which affects systemic hemodynamics.
- •congenital hereditary metabolic diseases.
- •parental informed consent was not obtained.
结局指标
主要结局
the duration of oxygen therapy
时间窗: 40 weeks
the duration of oxygen therapy of each group
the incidence of BPD
时间窗: 28 days
the incidence of BPD in each group
the average duration of mechanical ventilation
时间窗: 40 weeks
the average duration of mechanical ventilation of each group
次要结局
- the incidence of complications(40 weeks)
- oxygenation index and ventilation function (PaO2、a/APO2、FiO2、PaCO2)(the period of oxygen therapy)
- Pulmonary Severity Score (PSC)(1st, 2nd, 3rd, 7th, 14th, 28th days)
研究者
研究点 (2)
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