A Non-Interventional Follow Up Study For Subjects Who Received Sildenafil for Persistent Pulmonary Hypertension of the Newborn (PPHN)
2021年1月28日 更新者：Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
A Follow Up Investigation For Patients Completing Study A1481276 To Investigate Developmental Progress 12 And 24 Months Following Completion Of Sildenafil Treatment
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.
研究概览
详细说明
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.
研究类型
观察性的
注册 (实际的)
1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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London、英国、WC1N 3JH
- Great Ormond Street Hospital, Paediatric Intensive Care
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
1秒 至 1年 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Pediatric patients who took part in study A1481276 following PPHN treatment with IV sildenafil
描述
Inclusion Criteria:
- Any subject who received sildenafil treatment in study A1481276.
- Signed and dated informed consent document by legal guardian.
Exclusion Criteria:
- Any subject who did not receive sildenafil treatment during study A1481276.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 观测模型：其他
- 时间观点：预期
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants With Physical Examination Abnormalities at Month 12
大体时间：Month 12
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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.
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Month 12
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Number of Participants With Physical Examination Abnormalities at Month 24
大体时间：Month 24
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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.
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Month 24
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Number of Participants With Clinically Significant Medical History at Month 12
大体时间：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.
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Month 12
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Number of Participants With Clinically Significant Medical History at Month 24
大体时间：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.
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Month 24
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Overall Survival at Month 12
大体时间：Month 12
|
Overall survival was the duration from enrollment to death.
For participants who are alive, overall survival was censored at the last contact.
Number of participants who were alive at Month 12 was to be reported.
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Month 12
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Overall Survival at Month 24
大体时间：Month 24
|
Overall survival was the duration from enrollment to death.
For participants who are alive, overall survival was censored at the last contact.
Number of participants who were alive at Month 24 was to be reported.
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Month 24
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Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
大体时间：Up to Month 12
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An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
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Up to Month 12
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年11月1日
初级完成 (实际的)
2013年12月1日
研究完成 (实际的)
2013年12月1日
研究注册日期
首次提交
2013年1月8日
首先提交符合 QC 标准的
2013年2月27日
首次发布 (估计)
2013年3月1日
研究记录更新
最后更新发布 (实际的)
2021年2月1日
上次提交的符合 QC 标准的更新
2021年1月28日
最后验证
2021年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.