Development of a Hospital-Based Home Program for the Use of Inhaled Nitric Oxide in the Chronic Management of Severe Cardiopulmonary Diseases
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Mallinckrodt
- 入组人数
- 7
- 试验地点
- 3
- 主要终点
- Methemoglobin level
研究概览
简要总结
The purpose of this program is to evaluate the logistic issues and patient requirements for chronic pulsed INOmax delivery in ambulatory, home-care patients. To understand patient needs, patients with a variety of underlying diseases will be included. Safety of chronic therapy will be monitored by serial measurements of methemoglobin, platelet function assay and reported adverse events.
详细描述
This study will help develop a comprehensive home care program using INOmax delivery systems. This study will enroll a limited number of patients (5-7) from several disease categories in order to develop the experience with testing acute and chronic responsiveness to INO therapy. The following groups will be tested:
- Primary pulmonary hypertension (PPH)
- Severe pulmonary hypertension due to congenital (anatomic) heart disease
- Pulmonary hypertension or severe impairment of gas exchange in infants and children with chronic lung disease
- Pulmonary hypertension or severe impairment of gas exchange due to severe chronic lung disease in adults
- Pulmonary hypertension or severe impairment of gas exchange in hematologic and transplant disorders - young children and adults with sickle cell disease, chronic lung disease after bone marrow transplant, cardiac transplant, or lung transplant
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •The Principal Investigator has determined that the patient and/or caregiver is/are unable to manage safe administration of home nitric oxide therapy and maintain appropriate drug accountability and storage.
- •Women who are pregnant or nursing.
研究组 & 干预措施
1
Inhaled Nitric Oxide will be delivered through the INOpulse® at a Low Dose Range (3mL to 10mL; in 1mL increments) and Ultra Low Dose Ranges (0.5mL to 4mL; 0.5mL, then 1 to 4mL in 1mL increments).
干预措施: Inhaled Nitric Oxide (Drug)
结局指标
主要结局
Methemoglobin level
时间窗: 24 and 72 hours after treatment start, then at 1, 3, 6, 9 and 12 months
次要结局
- Vital Signs(taken at 1, 2, 3, 4, 24, and 72 hours after treatment begins, then at 1, 3, 6, 9 and 12 months)
- Adverse Event Occurence(Study Duration)
- Echocardiogram(At 72 hours after treatment start, then at 3, 6, 9 and 12 months)
- Pulse Oximetry(taken at 1, 2, 3, 4, 24, and 72 hours after treatment start and then at 1, 3, 6, 9 and 12 months)