A Clinical Study to Evaluate the Safety and Effectiveness of the Infinity Acute Care System Workstation Neonatal Care Babylog VN500 Device in High Frequency Oscillatory Ventilation (HFOV) Mode in Very Low Birth Weight (VLBW) Neonates
试验速览
- 阶段
- 不适用
- 入组人数
- 225
- 试验地点
- 28
- 主要终点
- Alive and free from Grade III/IV intraventricular hemorrhage (IVH) and cystic periventricular leukomalacia (PVL)
研究概览
简要总结
The purpose of this study is to determine the safety and effectiveness of the Babylog VN500 in high frequency oscillatory ventilation (HFOV) mode as a method for treating very low birth weight (VLBW) neonates requiring invasive respiratory support in the treatment of respiratory distress.
详细描述
Results from this single-arm, multi-center clinical study are intended to evaluate the safety and effectiveness of the Babylog VN500 device in high frequency oscillatory ventilation (HFOV) mode in very low birth weight (VLBW) neonates of 23 to 30 weeks' gestational age (400 g to 1200 g, inclusive) with documented respiratory distress requiring invasive respiratory support. The safety will be determined by evaluating the rate of subjects alive at Day 32 and free of Grade III/IV intraventricular hemorrhage (IVH) or cystic periventricular leukomalacia. Evaluation of the Alveolar-arterial (A-a) gradient 12 hours after start of ventilation will account for the effectiveness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 23 Weeks 至 30 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational Age between 23 to 30 weeks; within first 4 days of life
- •very low birth weight between 400 g and 1200 g, inclusive
- •5-minute Apgar score >3
- •documented respiratory distress requiring invasive respiratory Support
- •A priori: primary intention for either HFOV or high-frequency jet ventilation OR Severity of Illness: mechanical ventilation with a fraction of inspired oxygen of ≥ 0.25% and a mean airway pressure of ≥ 7 cm H2O, more than 2 hours after an initial dose of surfactant required and clinical care team believes that treatment with HFOV is indicated
- •anticipated availability of investigational device at the study center before screening for enrollment
- •written informed consent to participate in the study provided by a parent or legal guardian
排除标准
- •anticipation to require intubation and mechanical ventilation for less than 12 hours
- •previous exposure to any mechanical ventilation for ≥ 96 hours before planned HFOV treatment
- •obvious chromosomal or major congenital abnormalities involving the respiratory tract or upper airway
- •known congenital heart disease, excluding Patent Ductus Arteriosus (PDA), ventricular-septal defect, or atrial-septal defect
- •pre-existing air leak, including pneumothorax, pneumomediastinum, pneumopericardium, or extensive bilateral Pulmonary Interstitial Emphysema (PIE)
- •severe metabolic acidosis with a base deficit of ≥ 15 before planned HFOV treatment
- •severe hypotension (a mean blood pressure more than 2 standard deviations below the mean neonate's birth weight despite a total combined dose of dopamine, dobutamine, or both, of 20 µg(kg/min)
- •moribund subject not expected to survive, or a subject in whom there is a decision to limit care
- •currently receiving or previous treatment with inhaled nitric oxide
- •currently receiving or previous treatment with corticosteroids specifically for BPD prevention
- •evidence of severe sepsis (neutropenia, severe hypotension, shock)
- •evidence of Nectrotising Enterocolitis (NEC), defined as Modified Bell's Stage II or greater
- •documented Grade III/IV intraventricular hemorrhage
- •current enrollment in another Investigational Device Exemption or Investigational New Drug clinical study where treatment, testing, or follow-up may interfere with the results
研究组 & 干预措施
Babylog VN500 in HFOV mode
Subjects will be treated with HFOV provided by the Babylog VN500 - the investigational device - for up to 14 days.
干预措施: Babylog VN500 in HFOV Mode (Device)
结局指标
主要结局
Alive and free from Grade III/IV intraventricular hemorrhage (IVH) and cystic periventricular leukomalacia (PVL)
时间窗: Day 32 +/- 10 days gestational age
Papile's grading on cranial ultrasound
Alveolar-arterial (A-a) Gradient change
时间窗: 12 hours after onset of HFOV treatment
A-a Gradient as measured by arterial blood gas after onset of Treatment with the Babylog VN500 in HFOV mode
次要结局
- Freedom from study-defined serious adverse events(during Treatment Phase (up to 14 days))
- Device failure rate(during Treatment Phase (up to 14 days))
- Neurodevelopment assessment(22 - 24 months corrected age)
- Change of partial carbon dioxide pressure (PaCO2)(2, 6, 12, 24, 36 and 48 hours after onset of HFOV treatment)
- Relationship between tidal volume high frequency (Vthf) set and Vthf observed(2, 6, 12, 24, 36 and 48 hours and once daily after onset of HFOV treatment)
- Stability of Vthf observed and carbon dioxide diffusion (DCO2) coefficient monitoring during high frequency oscillation over time(first 48 hours of HFOV treatment)
- Freedom from Bronchopulmonary Dysplasia (BPD)(36 week's corrected age)
- Length and Type of Respiratory Support(participants will be followed for the duration of hospital stay, an expected average of 14 weeks)
- Neonatal survival(participants will be followed for the duration of hospital stay, an expected average of 14 weeks)