Non-invasive Ventilation as a Post Extubation Mode for RDS: a Randomized, Cotrolled Trial to Compare n-CPAP by n- Bipap and NIPPV
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Failure of extubation during the first 48 hours post-extubation
研究概览
简要总结
non-invasive ventilation in preterms complaining from RDS a randomized, controlled trial to compare between capap, n-bipap and NIPPV
详细描述
The primary aim of this study is to compare the impact of early extubation to nasal continuous positive airway pressure (n-CPAP) versus nasal Bilevel positive airway pressure (n-BiPAP) and non invasive positive pressure ventilation(NIPPV) on the need for mechanical ventilation via endotracheal tube (MVET) to 7 days of age or less in preterm infants less than or equal to 34 weeks' gestation requiring intubation and surfactant if indicated for respiratory distress syndrome within 120 min of delivery . Second aim is to compare different outcomes of post-extubation n-CPAP , n-BiPAPand NIPPV.
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
- 1 Day 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •preterm infants lessthan 34wk
排除标准
- •preterms less than 1000 g birth weight
- •infants with apgar 0at 1 min
- •presenceofany other cause of respiratory distress as: congenital malformation affecting the cardiorespiratory system ,neuromuscular disease ,fetal hydrops , interventricular hemorrhage and chromosomal aberrations
研究组 & 干预措施
n-CPAP
- The n-CPAP group will receive at extubation a single level continuous positive airway pressure of 7 cm water for at least 48 hours before weaning is commenced. If the infant is stable for the preceding 48 hours defined by having fewer than three minor apneas and no increase in oxygen requirement, weaning will be permitted.
- CPAP will be decreased from 6 cm water by 1 cm water every 24 hours if tolerated based on the above criteria. This will be done until a pressure of 4 cm water is reached.
- If a pressure of 4 cm water is successfully tolerated for 48 hours then time off n-CPAP will be allowed. Thereafter, no fixed weaning regime based on number of hours in a day the infant will be allowed to come off CPAP will be prescribed.
干预措施: N-CPAP (Device)
n-BiPAP
- The n-BiPAP group will receive at extubation a mean airway pressure of 7 cm water (positive end expiratory pressure of 5 cm water and peak inspiratory pressure of 9 cm of water). Inspiratory time of one second and respiratory rate of 30/min will always be maintained.
- The infant will then receive a mean airway pressure of 5 cm water (positive end expiratory pressure of 4 cm water and peak inspiratory pressure of 6 cm of water).
干预措施: n-BiPAP (Device)
NIPPV
o The NIPPV group will receive at extubation a positive end expiratory pressure of 5 cm water, peak inspiratory pressure of 15cm of water, RRof35 and Ti of 0.32
干预措施: NIPPV (Device)
结局指标
主要结局
Failure of extubation during the first 48 hours post-extubation
时间窗: during the first 48 hours post-extubation
This will be defined as: 1. Uncompensated respiratory acidosis defined as pH less than 7.2 and partial pressure of carbon dioxide of more than 60 mmHg (or) 2. Major apnea requiring mask ventilation
次要结局
- total days of non invasive ventilation(for 10 days from the hour of extubation)
- length of hospital stay(30 days postnatal age)
- pneumothorax(10 days post extubation)
研究者
Rania Ali El-Farrash
principal investigator
Ain Shams University