A Follow Up Investigation For Patients Completing Study A1481276 To Investigate Developmental Progress 12 And 24 Months Following Completion Of Sildenafil Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Number of Participants With Clinically Significant Medical History at Month 24
研究概览
简要总结
This single center study will monitor the developmental progress of PPHN patients who received iv sildenafil in study A1481276. Two visits will be conducted, at 12 and 24 months following the end of study drug infusion.
详细描述
This study will monitor developmental progress of PPHN patients for 2 years following study treatment, using Bayley III and Hammersmith tools. Data will be explored with descriptive statistics.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Years 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any subject who received sildenafil treatment in study A
- •Signed and dated informed consent document by legal guardian.
排除标准
- •Any subject who did not receive sildenafil treatment during study A1481276.
结局指标
主要结局
Number of Participants With Clinically Significant Medical History at Month 24
时间窗: Month 24
Criteria for clinically significant medical history included any hospital admissions or any medications given since discharge from Study A1481276 (NCT01069861) that were considered clinically significant by the investigator.
Number of Participants With Physical Examination Abnormalities at Month 12
时间窗: Month 12
Physical examinations included height, weight, head circumference, general appearance, skin examination, abdominal examination, respiratory system, neurological examination, hearing and ophthalmology assessments. Physical examination abnormalities were based on investigator discretion.
Number of Participants With Physical Examination Abnormalities at Month 24
时间窗: Month 24
Physical examinations included height, weight, head circumference, general appearance, skin examination, abdominal examination, respiratory system, neurological examination, hearing and ophthalmology assessments. Physical examination abnormalities were based on investigator discretion.
Number of Participants With Clinically Significant Medical History at Month 12
时间窗: Month 12
Criteria for clinically significant medical history included any hospital admissions or any medications given since discharge from Study A1481276 (NCT01069861) that were considered clinically significant by the investigator.
次要结局
- Overall Survival at Month 12(Month 12)
- Overall Survival at Month 24(Month 24)
- Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)(Up to Month 12)