Noninvasive Ventilation for Preterm Neonates With Respiratory Distress Syndrome: a Multi-center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 340
- 试验地点
- 1
- 主要终点
- Number of Participants Who Required 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 premature infants with RDS．
详细描述
Background: Invasive mechanical ventilation is associated with development of adverse pulmonary and non-pulmonary outcomes in very low birth weight infants. Various modes of non-invasive respiratory support are being increasingly used to minimize the incidence of bronchopulmonary dysplasia (BPD). The aim of this trials to compare the effect of noninvasive high-frequency oscillatory ventilation (NHFOV) and nasal continuous positive airway pressure (NCPAP) in preterm infants with respiratory distress syndrome (RDS) as a primary noninvasive ventilation support mode.
Methods/Design:In this multicenter, randomized, controlled trial, 300 preterm infants at gestational age (GA) less than 34 weeks with a diagnosis of RDS will be randomized to NHFOV or NCPAP as a primary mode of non-invasive respiratory support. Study will be conducted in 18 tertiary neonatal intensive care units in China.
The primary outcome is the need for invasive mechanical ventilation (IMV)during the first 7 days after enrollment in preterm infants randomized to the two groups. The secondary outcomes include days of hospitalization, days on noninvasive respiratory support, days on IMV, days on supplemental oxygen, mortality, need for surfactant, incidence of retinopathy of prematurity(ROP) and bronchopulmonary dysplasia(BPD), occurrence of abdominal distention, air leaks, intraventricular hemorrhage (IVH ≥ grade 3) and necrotizing enterocolitis (NEC> II stage). Other secondary outcomes include scores of Bayley Scales of Infant Development at 2 months and 2 years of corrected age.
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
- None
入排标准
- 年龄范围
- — 至 12 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1)Gestational age (GA) is from 26 to 34 weeks; (2) diagnosis of RDS. The diagnosis of RDS will be based on clinical manifestations (tachypnea, nasal flaring and or grunting) and chest X-ray findings; (3) RDS Silverman score>5; (4) informed parental consent has been obtained.
排除标准
- •(1) severe RDS requiring early intubation according to the American Academy of Pediatrics guidelines for neonatal resuscitation7; (2)major congenital malformations or complex congenital heart disease; (3) group B hemolytic streptococcus pneumonia, septicemia, pneumothorax, pulmonary hemorrhage; (4) cardiopulmonary arrest needing prolonged resuscitation; (5) transferred out of the NICUs without treatment.
结局指标
主要结局
Number of Participants Who Required Intubation
时间窗: during the first 7 days after birth
The criteria for endotracheal mechanical ventilation were as follows: severe respiratory acidosis (PaCO2 \> 60 mmHg with pH\<7.20), severe apnea and bradycardia (defined as recurrent apnea with \> 3 episodes per hour associated with heart rate \< 100/min, a single episode of apnea that required bag and mask ventilation), hypoxia (FiO2\>0.5 with PaO2\<50mmHg), severe respiratory distress, neonatal pulmonary hemorrhage, and cardiopulmonary arrest without effective resuscitation needing continued ventilation and rescue
次要结局
- the Incidence of Bronchopulmonary Dysplasia(BPD)(at a post-menstrual age of 36 weeks or at discharge)
- Length of Hospitalization(during hospitalization, up to 60 days)
- Number of Participants With Thick Secretions Causing an Airway Obstruction(during non-invasive ventilation, up to 15 days)
- the Incidence of Intraventricular Hemorrhage (IVH, ≥ Grade Ⅲ)(first two months after birth)
- the Incidence of Neonatal Necrotizing Enterocolitis(>Stage II)(during non-invasive ventilation, up to 7 days)
- The Score of Bayley Scales of Infant Development(30 months)
- the Incidence of Abdominal Distention(during non-invasive ventilation, up to 7 days)
- the Incidence of Pneumothorax(during non-invasive ventilation, up to 7 days)
- The Time of Non-invasive Ventilation(during non-invasive ventilation, up to 30 days)
- Length of O2 Therapy(during hospitalization, up to 60 days)
- the Incidence of Retinopathy of Prematurity (>Stage II)(at a post-menstrual age of 36 weeks or at discharge)
- Predischarge Mortality(during hospitalization, up to 60 days)
研究者
Xingwang Zhu
Director of neonatology
Jiulongpo No.1 People's Hospital