A Pilot Study to Evaluate the Safety of Perflurooctylbromide (PFOB) Partial Liquid Ventilation (PLV) for Up to 10 Days in Neonates With Severe Bronchopulmonary Dysplasia (BPD)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Sustained oxygen desaturations for greater than ten minutes without response to increased oxygen therapy
研究概览
简要总结
The primary study objective is to assess the safety and feasibility of perfluorooctylbromide (PFOB) partial liquid ventilation (PLV) in infants with severe Bronchopulmonary Dysplasia (BPD).
详细描述
The primary study objective is to assess the safety and feasibility of perfluorooctylbromide (PFOB) partial liquid ventilation for up to ten days in infants with severe BPD as evaluated by: (1) no sustained oxygen desaturations (SpO2 ≤ 80%) for greater than ten minutes without response to increased oxygen therapy, (2) no persistent hypotension without response to volume expansion and/or inotropic therapy, (3) no major mucus plugging events (defined as events that are unresolved after two bronchoscopes), (4) no pneumothoraces or pleural effusion with PFOB, (5) and no evidence of increased carbon dioxide (CO2) retention, renal insufficiency, hyperkalemia, or metabolic acidosis.
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
- — 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Perfluorooctylbromide (PFOB) Group
Subjects in the PFOB group will be administered an initial PFOB treatment dose of 2.5 mL/kg and up to a total intra-pulmonary volume of 25 mL/kg for up to 10 days.
干预措施: Perfluorooctyl Bromide (Drug)
结局指标
主要结局
Sustained oxygen desaturations for greater than ten minutes without response to increased oxygen therapy
时间窗: Day 5, Day 10
Incidence of sustained (greater than 10 minutes) oxygen desaturation events without response to increased oxygen therapy. These incidences will be measured by a continuous non-invasive percutaneous oxygen saturation monitor.
Persistent hypotension without response to volume expansion and/or inotropic therapy
时间窗: Day 5, Day 10
Incidence of persistent hypotension without response to volume expansion and/or inotropic therapy. Hypotension is a decrease in systolic blood pressure deemed significant by clinical staff. Measurement will be performed with a standard intensive care unit blood pressure cuff.
Change in number of major mucus plugging events
时间窗: Day 5, Day 10
Incidence of airway obstruction of the endotracheal tube, as indicated by decreased chest movement during mechanical ventilation, need for increased ventilator pressure, and/or elevation of carbon dioxide levels in the blood. Mucus plugs are confirmed by endotracheal suctioning.
Incidence of pneumothorax or pleural effusion with PFOB
时间窗: Day 5, Day 10
Incidence of pneumothorax in the child will be measured by transillumination of the chest and confirmed by chest x-ray.
Number of participants with sustained hypercapnia (elevated carbon dioxide in the blood, greater than 95 mmHg, for over four hours).
时间窗: Day 5, Day 10
Hypercapnia will be measured with blood tests and/or cutaneous carbon dioxide monitor.
次要结局
- Change in fraction of inspired oxygen (FiO2)(Day 5, Day 10)
- Change in Respiratory Severity Score (MAP x FiO2)(Day 5, Day 10)
- Change in ventilator mean airway pressure (MAP)(Day 5, Day 10)
研究者
William Fox
Attending Physician
Children's Hospital of Philadelphia