Principal Investigator
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Incidence of bronchopulmonary dysplasia
研究概览
简要总结
Respiratory distress syndrome (RDS) is common in preterm infants born at less than 32 weeks gestation; surfactant and mechanical ventilation have been the standard treatment. However, despite advances in neonatal respiratory care, a considerable number of preterm infants develop chronic lung disease, termed bronchopulmonary dysplasia (BPD), which is associated with neonatal death, prolonged neonatal intensive care stay, and impaired neurodevelopment. High-frequency oscillatory ventilation (HFOV) was developed as a new ventilation technique in the late 1970s. It was expected to result in less BPD and death as a primary model of ventilation compared to conventional ventilation (CV) in the treatment of RDS. However, there is disagreement concerning the advantage of HFOV over CV in the treatment of RDS in preterm infants regarding the prevention of death, BPD, intraventricular hemorrhage, and periventricular leucomalacia in the short term. The purpose of this study was to compare the efficacy and safety of HFOV and CV in preterm infants with severe RDS.
详细描述
All patients were monitored including blood pressure, heart rate, oxygen saturation, ventilator settings, and arterial blood gases pre- or during mechanical ventilation. PaO2/FIO2 was calculated. After 2 hours ventilation, if PaO2/FIO2 <200, patients were given rescue surfactant therapy (Curosurf 200mg/kg). A subsequent dose (100mg/kg) was administered when PaO2/FIO2 <200 12 hours after the previous dose. Surfactant was administered with use of in-line catheters. Suctioning was performed 6 hours after surfactant administration, except for some patients needed suction soon, with use of an in-line suction catheter. Ventilation continued during the administration of surfactant and suctioning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 24 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants admitted to the NICU with gestational age <32 weeks, birth weight <1500g and less than 24 hours of age
- •Who developed RDS requiring mechanical ventilation
- •Presented a partial pressure of oxygen (PaO2): fraction of inspired oxygen (FIO2) ratio <200
- •Radiograph criteria of severe RDS
排除标准
- •Infants with genetic metabolic diseases
- •Congenital abnormalities
- •Pneumothorax
- •Grade III-IV intracranial hemorrhage
结局指标
主要结局
Incidence of bronchopulmonary dysplasia
时间窗: defined as requirement of oxygen at 36 weeks of postmenstrual age
To count the number of patients with bronchopulmonary dysplasia at 36 weeks of postmenstrual age.
次要结局
- duration of mechanical ventilation(number of days on mechanical ventilation after birth to 36weeks of postmenstrual age)
研究者
Changlian Zhu
Professor
Zhengzhou Children's Hospital, China