Treprostinil in Newborns With Pulmonary Hypertension; a Noninterventional Study to Collect Data on Drug Utilization, Safety, and Effectiveness.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Characteristics of neonates receiving treprostinil in the clinical practice.
研究概览
简要总结
This observational study will seek to describe the uses and safety and efficacy outcomes of treprostinil in clinical practice in patients with persistent pulmonary hypertension (PPHN).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- — 至 44 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborn infants who received at least one dose of IV or SC treprostinil as per clinical practice within 5 years from the moment of data collection.
- •Aged up to 44 weeks after conception at treprostinil initiation.
- •Pulmonary hypertension (PH) or suspicion of PH at the moment of treprostinil initiation.
- •Parent(s) or legally authorized representative(s) provides non-opposition consent for the patient participation in the study.
- •Newborn infants affiliated to French social security.
排除标准
- 未提供
结局指标
主要结局
Characteristics of neonates receiving treprostinil in the clinical practice.
时间窗: From baseline to Day 30 after last dose of treprostinil
Sex (male/female) ; Gestational Age (weeks) ; Birth Weight (g) ; Apgar (1 and 5 min, 0-10) and Time from birth to treprostinil initiation (h)
Number of participants with treatment-related adverse events to evaluate safety.
时间窗: From baseline to Day 30 after last dose of treprostinil
Treprostinil-specific treatment patterns.
时间窗: From baseline to Day 30 after last dose of treprostinil
Prior concomitant treatments, treprostinil route, treprostinil dose(s) (mg/ml) and treprostinil treatment duration (days).
次要结局
- Description of neurodevelopmental progress over 2 years after treprostinil initiation through a Global Clinical Impression Scale.(From day 30 after treprostinil treatment to Year 2 after last dose of treprostinil)
- Composite endpoint of absence of complications through Day 14 after the index date.(From baseline to Day 30 after last dose of treprostinil)
- Description of the clinical outcomes from treprostinil start day (i.e., Day 0) to Day 14 and at Day 30 after last dose of treprostinil.(0h, 24h, 48h, 72h, Day 7, Day 14, and Day 30 after last dose of treprostinil (if applicable).)