A Non-Interventional Follow Up Study For Subjects Who Received Sildenafil for Persistent Pulmonary Hypertension of the Newborn (PPHN)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Follow Up Investigation For Patients Completing Study A1481276 To Investigate Developmental Progress 12 And 24 Months Following Completion Of Sildenafil Treatment

Conditions
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Pulmonary Hypertension, Persistent, of the Newborn

Intervention / Treatment
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* Other: non-interventional


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: non-interventional|non-interventional|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Physical Examination Abnormalities at 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. | Month 12 | 
| Number of Participants With Physical Examination Abnormalities at 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. | Month 24 | 
| Number of Participants With Clinically Significant Medical History at 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. | Month 12 | 
| Number of Participants With Clinically Significant Medical History at 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. | Month 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival at 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. | Month 12 | 
| Overall Survival at 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. | Month 24 | 
| Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | 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. | Up to Month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PPHN; development progress after PPHN; developmental progress after sildenafil.