Effectiveness of Non-invasive High Frequency Oscillatory Ventilation (nHFOV) Versus Invasive Conventional Ventilation for Preterm Neonates With Respiratory Distress Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Weaning from Assigned respiratory support
研究概览
简要总结
Preterm neonates usually develop respiratory distress syndrome (RDS) for which they need respiratory support, which may be invasive and non-invasive depend on the availability and individual need. Non-invasive is relatively safe but non-invasive high frequency oscillatory ventilation (nHFOV) is not appropriately evaluated in neonates as primary support. So the investigators hypothesized that nHFOV is relatively safe and effective in comparison with invasive ventilation for preterm neonates with RDS.
详细描述
Respiratory distress is a common morbidity in preterm neonates that requires respiratory support and surfactant replacement, if not adequately and timely managed may cause multi-organ dysfunction. Respiratory support can be delivered via both non-invasive (NIV) and invasive mode depending upon the availability of ventilators ,experience and comfort level of physician, and availability of department protocol.
Non-invasive ventilation include CPAP (Continuous Positive Airway Pressure), NIPPV (Non-invasive Positive Pressure Ventilation) and nHFOV (Non-invasive High Frequency Oscillatory Ventilation). Non-invasive ventilation is currently the preferred mode of ventilation globally due to its safety profile, early weaning, less barotrauma, volume trauma and other complications.
Literature review reveals reported comparison for some non-invasive modes of ventilation like CPAP and NIPPV versus conventional ventilation however other non-invasive modes such as nHFOV have still not been appropriately evaluated. nHFOV provides 60-1200 breath/minute with minimal tidal volume while keeping the lungs expanded with equal distribution of air in whole lung so less chances of barotrauma and volutrauma. Extra pressure which is not needed by the lung is dissipated through oral cavity and esophagus to the stomach. Few observational studies reported that extubation failure is better prevented with utilization of NHFOV.
For preterm neonates with RDS nHFOV compared with nCPAP showed better results in term of short duration of intervention, less chances of failure, low incidence of intraventricular hemorrhage, and other respiratory complications were almost equal.
A multicenter double, blinded, randomized controlled trial is under process for using non-invasive ventilation to prevent extubation failure. Another randomized controlled cross over trial performed in a small number of extreme preterm does showed better clearance of carbon dioxide with nHFOV compared with CPAP.
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 Hour 至 6 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inborn Preterm Neonates 26-34 weeks gestation admitted to NICU with diagnosis of RDS
- •Babies who were initially started on High Flow Oxygen Therapy/nCPAP but unable to maintain saturation > 90% on fio2 of 40% in 1st 6 hours of life.
- •Capillary PCO2 of > 70 or arterial PCO2 > 65 on two repeated sampling within 4 hours
- •Neonates whose parents consented to participate.
排除标准
- •All preterm babies who are below < 26 weeks above the 34 weeks of gestation
- •Preterm neonates (26-34 weeks) with diagnosis of RDS requiring endotracheal intubation within Labor room/Operation Theater or within 1st hour of life for respiratory support.
- •Preterm Neonates with the gestational age of 26-34 weeks, diagnosed as congenital pneumonia or sepsis.
- •Patient with poor respiratory drive due to any reason neurological or central causes
- •Diaphragmatic hernia or any other thoracic anomaly
- •Pleural effusion unilateral or bilateral
- •Congenital cystic pulmonary malformation.
- •Neonates with underlying cyanotic heart disease.
- •Neonates with acynotic heart disease causing pulmonary edema
- •Neonates with cleft lip and cleft palate or any other surgical condition.
结局指标
主要结局
Weaning from Assigned respiratory support
时间窗: within 1-2 weeks of respiratory support starting
Babies started on intervention or comparator will be monitored for weaning from respiratory support in hours after starting respiratory support.
Oxygen Requirement
时间窗: Within first 24 hours
With assigned intervention or comparator, baby will be monitored for oxygen requirement comparing with baseline oxygen demand or \> 40% of fractional Inspiratory oxygen.
Respiratory Support Escalation
时间窗: within first 24 hours of intervention
After starting with intervention or control group, baby will be monitored for further escalation of respiratory support like baby is Conventional Invasive Ventilation needs High frequency oscillatory ventilation. Baby started on NHFOV need invasive ventilation.
次要结局
- Number of Surfactant Needed(within first 3 days of assignment)
- Complications related to respiratory support(Within 1 week after respiratory support discontinuation)
- Respiratory Support Duration(up to 2 weeks)
- Complication related to prematurity(Within 1week)