RAM Cannula Versus Short Binasal Prong Interfaces of Non- Invasive Ventilation for Prevention of Extubating Failure in Preterm Infants: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Failure of extubation incidence rate
研究概览
简要总结
Nowadays, the use of non-invasive ventilation for preterm infants in the NICU has increased to avoid complications associated with prolonged endotracheal intubation. Adequate pressure delivery through non-invasive ventilation is essential, as it enhances the growth and development of premature lungs. Various interfaces have been used to ensure proper sealing. The RAM cannula, used as an interface for non-invasive respiratory support in preterm neonates, is associated with reduced nasal trauma compared to short binasal prongs (SBPs), due to its softer material, making it a safer option. However, the RAM cannula has been shown to deliver lower pharyngeal pressure and, therefore, may not maintain airway pressure as consistently as nasal prongs. Currently, limited data is available regarding the efficacy of nasal prongs compared to the RAM cannula as a post-extubation interface for non-invasive ventilation support in preterm infants. Additionally, we have observed that the use of the RAM cannula for non-invasive ventilation in preterm infants is associated with a longer duration of oxygen therapy compared to SBPs.
The investigators hypothesize that the RAM cannula provides a lower level of positive end-expiratory pressure compared to SBPs during non-invasive ventilation.
The investigators aim to assess the efficacy and safety of the RAM cannula versus SBPs as nasal interfaces for post-extubation non-invasive respiratory support in preterm infants.
详细描述
Preterm infants will be randomized to receive post-extubation non invasive respiratory support either through RAM cannula or SBPs. Neonates in both groups will be uniformly managed as per unit protocol as following:
Extubation criteria :
- Birth weight < 1000 gram :MAP <7 cmH2O and FIO2 <0.30
- Birth weight>1000 gram :MAP >8 cmH2O and FIO2 <0.30
Re intubation criteria :
- FIO2>0.60 to maintain SaO2 >88% OR PaO2 > 45 mmHg
- PaCO2 {arterial} > 55-60 with PH < 7.25
- Apnea and requiring bag and mask ventilation
- Evidence of increased work of breathing {retractions -grunting -chest wall distortion } plus abnormal chest x ray
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
- 24 Hours 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inborn preterm neonates ≤ 32 weeks of gestational and/or birth weight ≤1500 g with respiratory distress syndrome requiring initial invasive ventilation support for at least 24 hours.
排除标准
- •Outborn preterm neonates
- •Major congenital malformations.
研究组 & 干预措施
RAM cannula group
Preterm infants will receive non-invasive ventilation by RAM cannula
干预措施: RAM cannula (Other)
Short binasal prong group
Preterm infants will receive non-invasive ventilation by short binasal prongs
干预措施: Short binasal prong (Other)
结局指标
主要结局
Failure of extubation incidence rate
时间窗: 28 days of an infant's life
Need for reintubation within 72 hours post-extubation trial
次要结局
- Duration of non-invasive ventilation(120 days)
- whole duration of oxygen therapy(120 days)
- Diaphragmatic indices and lung ultrasound scores post-extubation (pre & post extubation then weekly)(120 days)
- Need for reintubation within 7 days(28 days of an infant's life)
- Bronchopulmonary dysplasia(120 days)
- Mortality(120 days)
研究者
hussam murayh mohammed ali
Fellow of Neonatal- perinatal medicine, NICU
Ministry of Health, Saudi Arabia