NCT05144724已完成不适用
Volume Targeted Mask Ventilation Versus Pressure Ventilation in Preterm Infants
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Percentage of of eligible participants (=infants requiring PPV) who have the intervention performed correctly without protocol deviation (=cross over to control group when randomized to VTV-group)
研究概览
简要总结
This is a pilot trial to assess the feasibility of volume Targeted Ventilation in the Delivery Room.
Preterm infants will be randomized to pressure guided or volume targeted ventilation during respiratory support in the delivery room
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 0 Minutes 至 1 Minute（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Born between 23+0/7 to 28+6/7 weeks' gestation
- •Considered suitable for full resuscitation, i.e., no parental request or antenatal decision to forego resuscitation
- •Informed parental consent
排除标准
- •Major congenital or chromosomal malformation
- •Conditions that might have an adverse effect on breathing or ventilation (e.g., high risk for lung hypoplasia, congenital diaphragmatic hernia)
- •Congenital heart disease requiring intervention in the neonatal period
- •Hydrops requiring intervention in the neonatal period
- •Neonatal resuscitation initiated before NICU team arrival
- •Infants who are born outside of study center and transported to center after delivery
研究组 & 干预措施
Volume Targeted Ventilation
Experimental
Positive pressure ventilation will be provided using a set tidal volume
干预措施: Volume targeted ventilation (Procedure)
Pressure guided Ventilation
Active Comparator
Positive pressure ventilation will be provided using a set peak inflation pressure
干预措施: Pressure targeted ventilation (Procedure)
结局指标
主要结局
Percentage of of eligible participants (=infants requiring PPV) who have the intervention performed correctly without protocol deviation (=cross over to control group when randomized to VTV-group)
时间窗: Through study completion (total 18 months)
Percentage of Participants who have received allocated treatment
次要结局
- Number of participants with mortality(up to 6 months of NICU admission)
- Number of participants with severe brain injury on cranial ultrasound(up to 6 months of NICU admission)
- Number of participants with severe retinopathy of prematurity (stage 3 or higher)(up to 6 months of NICU admission)
- Number of participants with bronchopulmonary dysplasia at 36 weeks corrected age(At 36 weeks corrected age)
- Number of participants with Bronchopulmonary dysplasia at 40 weeks corrected age(At 40 weeks corrected age)
- Total duration of mechanical ventilation via an endotracheal tube in days(Days during NICU admission (up to 6 months))
- Number of participants discharge home on oxygen(At time of NICU discharge (with 6 moths from birth))
- Duration of any respiratory support in days(Days during NICU admission (up to 6 months))
- Duration of supplemental oxygen in days(Days during NICU admission (up to 6 months))
- Length of hospital stay in days(Number of days from birth to discharge (up to 6 months))
- Rate of intubation in the delivery room(within 60min after birth)
- Rate of chest compression in the delivery room(within 60min after birth)
- Rate of pneumothorax(up to 6 months of NICU admission)
- Number of participants with necrotizing enterocolitis(up to 6 months of NICU admission)
- Duration of positive pressure ventilation at birth in days(within the first 10 min after birth)
研究者
研究点 (1)
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