Volume Targeted Mask Ventilation Versus Pressure Ventilation in Preterm Infants

University of Alberta1 个研究点分布在 1 个国家目标入组 52 人2024年10月1日

适应症Neonatal Respiratory Distress

干预措施Volume targeted ventilation Pressure targeted ventilation

概览

阶段: 不适用
干预措施: Volume targeted ventilation
疾病 / 适应症: Neonatal Respiratory Distress
发起方: University of Alberta
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)
状态: 已完成
最后更新: 3个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

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

注册库

clinicaltrials.gov

开始日期

2024年10月1日

结束日期

2025年12月17日

最后更新

3个月前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

University of Alberta

责任方

Sponsor

入排标准

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

Positive pressure ventilation will be provided using a set tidal volume

干预措施: Volume targeted ventilation

Pressure guided Ventilation

Positive pressure ventilation will be provided using a set peak inflation pressure

干预措施: Pressure targeted ventilation

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)