Efficacy of RAM Cannula vs Nasal Mask as an Interface in Primary Respiratory Support with Non-Invasive Positive Pressure Ventilation(NIPPV) in Preterm Infants (28–36 weeks GA) with Respiratory Distress – A Randomised Controlled Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 246
- 试验地点
- 1
研究概览
简要总结
The effectiveness of non-invasive ventilation is largely influenced by the interface used for pressure delivery. Commonly used interfaces include short binasal prongs and nasal masks . Randomised trials and systematic reviews have shown that nasal masks are associated with reduced air leaks, better pressure transmission, and lower incidence of nasal injury compared to prongs. However, both interfaces may still cause complications such as septal trauma and discomfort, limiting their long-term use.
This will be a prospective, randomized control, single-centre, clinical trial comparing the effectiveness of Ram cannula vs Nasal mask as an interface in primary respiratory support with NIPPV in preterm infants (28-36 weeks GA) with respiratory distress. Informed consent from parents will be taken.Outcomes as described will be noted from time to time. In case of failure in any mode, babies will be managed accordingly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 1.00 Day(s) 至 3.00 Day(s)（—）
- 性别
- All
入选标准
- •Infants born more or equal 28 weeks of gestation
- •Inborn babies up to postnatal age 72 hours
- •Evidence of respiratory distress (SAS Score more than 3).
排除标准
- •Babies lesss than 28 weeks of gestational age at birth
- •Outborn babies
- •Major congenital anomalies or known/suspected chromosomal anomalies
- •Upper airway anomalies
- •Severe perinatal asphyxia (blood gas pH less than 7.0 and BE more than-12) 6.
研究者
Dr Bijan Saha
IPGMER and SSKM Hospital