Pulmonary Hypertension, Persistent, of the Newborn
Conditions
Keywords
PPHN; development progress after PPHN; developmental progress after sildenafil.
Brief summary
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
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.
Interventions
OTHERnon-interventional
non-interventional
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Years to 1 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Physical Examination Abnormalities at Month 12 | 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 | 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 | 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. |
| Number of Participants With Clinically Significant Medical History at Month 24 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival at Month 24 | 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. |
| Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Up to Month 12 | 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. |
| Overall Survival at Month 12 | 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. |
Countries
United Kingdom
Participant flow
Recruitment details
All participants who received sildenafil treatment during study A1481276 (NCT01069861) were eligible for enrollment in this study.
Participants by arm
| Arm | Count |
|---|---|
| Sildenafil Participants who received intravenous (IV) sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24. | 1 |
| Total | 1 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Sildenafil |
|---|---|
| Age, Continuous | 1.2 years |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
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.
Time frame: Month 12
Population: Full Analysis Set (FAS) included all enrolled participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sildenafil | Number of Participants With Clinically Significant Medical History at Month 12 | 0 participants |
Primary
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.
Time frame: Month 24
Population: Data was not possible to report as participant lost to follow-up at Month 24 (Visit 2) after Month 12 follow-up (Visit 1).
Primary
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.
Time frame: Month 12
Population: Full Analysis Set (FAS) included all enrolled participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sildenafil | Number of Participants With Physical Examination Abnormalities at Month 12 | 0 participants |
Primary
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.
Time frame: Month 24
Population: Data was not possible to report as participant lost to follow-up at Month 24 (Visit 2) after Month 12 follow-up (Visit 1).
Secondary
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.
Time frame: Up to Month 12
Population: FAS included all enrolled participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sildenafil | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | 0 participants |
Secondary
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.
Time frame: Month 12
Population: Full Analysis Set (FAS) included all enrolled participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sildenafil | Overall Survival at Month 12 | 1 participants |
Secondary
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.
Time frame: Month 24
Population: Data was not possible to report as participant lost to follow-up at Month 24 (Visit 2) after Month 12 follow-up (Visit 1).