Clinical efficacy of synchronized nasal intermittent positive pressure ventilation versus high continuous positive airway pressure as primary mode of respiratory support in preterm neonates(28-34weeks): 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
- 108
- 试验地点
- 1
- 主要终点
- Requirement of intubation within 72 hrs of assigned mode/ use of alternative mode of non invasive support
研究概览
简要总结
This study is a randomized controlled trial comparing the clinical efficacy of two non-invasive ventilation methods—Synchronized Nasal Intermittent Positive Pressure Ventilation (NIPPV) and High Continuous Positive Airway Pressure (CPAP)—in preterm neonates (28-34 weeks). The trial aims to determine which method is more effective as the primary mode of respiratory support for neonates experiencing respiratory distress.
Key objectives include:
- Primary Objective: Assess the need for intubation within 72 hours of starting the assigned mode.
- Secondary Objectives: Examine other clinical outcomes such as the duration of respiratory support, feeding tolerance, the occurrence of necrotizing enterocolitis (NEC), pulmonary air leaks, and length of stay in the neonatal intensive care unit (NICU).
The study will be conducted at IPGMER & SSKM Hospital in Kolkata and will involve 108 participants, randomly assigned to one of the two groups.
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
- 0.00 Day(s) 至 3.00 Day(s)（—）
- 性别
- All
入选标准
- •All Intramural Preterm (28 to 34 weeks GA) neonate within 72 hrs of life with respiratory distress.
排除标准
- •Major Congenital anomalies Suspected Chromosomal anomalies Requirement of Vasopressor/ mechanical ventilation/ hemodynamically unstable at the time of randomisation Severe Perinatal asphyxia Upper airway anomalies Outborn neonates.
结局指标
主要结局
Requirement of intubation within 72 hrs of assigned mode/ use of alternative mode of non invasive support
时间窗: Requirement of intubation within 72 hrs of assigned mode/ use of alternative mode of non invasive support
次要结局
- Duration of respiratory support(At 4 weeks)
- Requirement of intravenous fluid before reaching full feeds(At 2 weeks)
- Incidence of feed intolerance(At 4 weeks)
- Incidence of NEC(At 4 weeks)
- Incidence of pulmonary air leak(At 4 weeks)
- Incidence of IVH(At 4 weeks)
- Incidence of culture positive sepsis(At 4 weeks)
- Incidence of BPD(At 4 weeks)
- Incidence of hsPDA requiring treatment(At 4 weeks)
- Incidence of ROP(At 4 weeks)
- Length of NICU stay(At 4 weeks)
研究者
Madhurima Ganguly
Institute of Post Graduate Medical Education and Research,Kolkata