HHHFNC to Prevent Extubation Failure in Preterm Infants: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Extubation failure
研究概览
简要总结
This is a randomized controlled trial (RCT) to evaluate the influence of two flow rates (6 liter/min versus 3 liter/min) of Heated-Humidified High-Flow-Nasal-Cannula (HHHFNC) on rates of extubation failure in mechanically ventilated preterm infants.
详细描述
HHHFNC has been proposed as an alternative to nasal continuous positive airway pressure (nCPAP) in neonatal intensive care units (NICUs) for preventing extubation failure. In a recent international survey on periextubation practices in extremely preterm infants, nCPAP was the most common type of respiratory support used (84%) followed by nasal intermittent positive pressure ventilation (55%) and HHHFNC (33%). Moreover, HHHFNC appears to have efficacy and safety similar to those of nCPAP when applied immediately post-extubation to prevent extubation failure in preterm infants. and resulted in significantly less nasal trauma in the first 7 days post-extubation than nCPAP. However, the best flow rates of HHHFNC to prevent extubation failure remains to be known.
This RCT aims to compare the efficacy and safety of postextubation respiratory support via HHHFNC at two different flow rates (6 L/min. versus 3 L/min) regarding successful extubation after a period of endotracheal positive pressure ventilation. We hypothesized that postextubation respiratory support via HHHFNC at a flow rate of 6 L/min. will result in a greater proportion of preterm infants being successfully extubated after a period of endotracheal positive pressure ventilation compared with HHHFNC at a flow rate of 3 L/min.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Hour 至 30 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants born at less than 37 weeks' gestation, required endotracheal intubation and positive pressure ventilation, and are considered ready for extubation by the clinical team. Infants will be enrolled after written informed parental consent is obtained.
排除标准
- •Suspected upper airway obstruction, congenital airway malformations, or major cardiopulmonary malformations
结局指标
主要结局
Extubation failure
时间窗: the 7 days after extubation
Extubation failure criteria will be defined as follows: 1. Apnea (respiratory pause \>20 seconds), more than 6 episodes requiring physical stimulation in 6 hours or 1 requiring intermittent positive pressure ventilation. 2. Respiratory acidosis with pH \<7.25 and Peripheral arterial oxygen saturation (PaCO2) \>65 mmHg. ( \>15% sustained increase in FiO2 from extubation. 4. Cardiovascular collapse (heart rate \<60 beats per minute or shock. 5. Persistent marked/severe retractions. Extubation failure will be deemed to occur if any single criterion was met in any one of the 7 days after extubation. The decision to reintubate an infant and mechanical ventilation variables and subsequent extubation attempts after reintubation will be managed at the discretion of the clinical team.
次要结局
- Total duration of mechanical ventilation(During NICU admission with expected average of 5 weeks)
- Total duration of oxygen supplementation(During NICU admission with expected average of 5 weeks)
- Bronchopulmonary dysplasia (BPD)(at 36 weeks' post-menstrual age.)
- Severe BPD(at 36 weeks' post-menstrual age.)
- The combined outcome variables of death before 36 weeks PMA or BPD(at 36 weeks' post-menstrual age.)
- The combined outcome variables of death before 36 weeks PMA or severe BPD(at 36 weeks' post-menstrual age)
- Other neonatal morbidities (intracranial hemorrhage, pneumothorax, patent ductus arteriosus, necrotizing enterocolitis, and retinopathy of prematurity)(baseline, during the 96 hours post-extubation, and at any time thereafter during NICU stay with an expected average of 5 weeks)
- Mortality(within the 96 hour post-extubation period or at any time after with expected average of 5 weeks)
研究者
Hesham Abdel-Hady
Professor of Pediatrics
Mansoura University Children Hospital