Bi-level Positive Airway Pressure for Respiratory Distress Syndrome in Twins:A Randomized Controlled Trials
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- intubation rate
研究概览
简要总结
The investigators compared advantages and disadvantages of two forms of noninvasive respiratory support -bi-level positive airway pressure(BiPAP) 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 bi-level positive airway pressure(BiPAP) 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 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 resuscitation;
- •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 rate
时间窗: within 7 days
the baby was intubated
次要结局
未报告次要终点
研究者
Ma Juan
Principal Investigator
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University