Nasal Intermittent Positive Pressure Ventilation vs Continuous Positive Airway Pressure for Preterm Infants With Respiratory Distress Syndrome:a Multicenter Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- intubation rate
研究概览
简要总结
In the past, several studies have compared the effects between nasal intermittent positive pressure ventilation(NIPPV) and nasal continuous positive airway pressure(NCPAP) on the incidence of intubation in preterm infants, and the results were inconsistent.The purpose of the present study was to compare NIPPV with NCPAP on the need for endotracheal ventilation and subsequent complications
详细描述
To this day, early use of noninvasive respiratory support strategies has been suggested to be the most effective pathway to reduce those risks. Nasal continuous positive airway pressure (NCPAP) and nasal intermittent positive pressure ventilation (NIPPV) are two widely used ways of noninvasive ventilation strategies in preterm infant. As compared with invasive ventilation, NCPAP reduces the risks abnormal neurodevelopment. However, there is only 60% success rate of avoiding intubation in the preterm neonate supported with NCPAP. Supplying with an intermittent peak pressure on NCPAP, NIPPV is considered as a strengthened version of NCPAP with increased flow delivery in the upper airway, increased minute volume and functional residual capacity and recruitment of collapsed alveoli, improved stability of the chest wall and reduced asynchrony of thoraco-abdominal movement,which have been proven to be crucial to decrease the incidences of invasive ventilation and death. However, studies have compared the effects between nasal intermittent positive pressure ventilation(NIPPV) and nasal continuous positive airway pressure(NCPAP) on the incidence of intubation in preterm infants, and the results were inconsistent.
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 RDS. The diagnosis of respiratory distress syndrome(RDS) will be based on clinical manifestations (tachypnea, nasal flaring and or grunting) and chest X-ray findings;
- •RDS Silverman score>5;
- •Informed parental consent has been obtained.
排除标准
- •Severe RDS 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.
研究组 & 干预措施
NIPPV
NIPPV is used as a primary mode of ventilation in premature infants with respiratory distress syndrome
干预措施: NIPPV (Device)
NCPAP
NCPAP is used as a primary mode of ventilation in premature infants with respiratory distress syndrome
干预措施: NCPAP (Device)
结局指标
主要结局
intubation rate
时间窗: within 7 days
the infant is intubated ventilation
次要结局
- Intraventricular hemorrhage(within 28 days)
- bronchopulmonary dysplasia(at a post-menstrual age of 36 weeks or at discharge)
- Bayley Scales of Infant Development(at 2 months old and 2 years old)
- Neonatal necrotizing enterocolitis(NEC)(within 7 days)
研究者
Ma Juan
Principal Investigator
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University