Nasal High Frequency Oscillation for Respiratory Distress Syndrome in Preterm Twins Infants
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- intubation
研究概览
简要总结
The investigators compared advantages and disadvantages of two forms of noninvasive respiratory support -noninvasive high-frequency oscillatory ventilation (nHFOV) or nasal continuous positive airway pressure (nCPAP) -as a primary mode of ventilation in preterm twins infants with respiratory distress syndrome
详细描述
Invasive ventilation is related to development of adverse pulmonary and nonpulmonary outcomes in ventilated infants. Various modes of noninvasive respiratory support are being increasingly used to minimize the incidence of bronchopulmonary dysplasia (BPD). The aim of this trial to compare the effects of noninvasive high frequency oscillatory ventilation (NHFOV) and nasal continuous positive airway pressure (NCPAP) in preterm twins infants as the primary mode.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Minutes 至 6 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age (GA) is from 26 to 37 weeks;
- •Diagnosis of respiratory distress syndrome. The diagnosis of respiratory distress syndrome will be based on clinical manifestations (tachypnea, nasal flaring and or grunting) and chest X-ray findings;
- •Respiratory distress syndrome Silverman score >5;
- •Informed parental consent has been obtained.
排除标准
- •Severe respiratory distress syndrome requiring early intubation according to the American Academy of Pediatrics guidelines for neonatal resuscitation7;
- •Major congenital malformations or complex congenital heart disease;
- •Group B hemolytic streptococcus pneumonia, septicemia, pneumothorax, pulmonary hemorrhage;
- •Cardiopulmonary arrest needing prolonged resuscitation;
- •transferred out of the neonatal intensive care unit without treatment.
结局指标
主要结局
intubation
时间窗: during the first 7 days after birth
the baby is re-intubated.
次要结局
- Bronchopulmonary dysplasia(BPD)(at a post-menstrual age of 36 weeks or at discharge)
- Bayley Scales of Infant Development(30 months after birth)
研究者
Ma Juan
director
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University