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.
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.
Study Type
OBSERVATIONAL
Enrollment
1
non-interventional
Great Ormond Street Hospital, Paediatric Intensive Care
London, United Kingdom
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
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
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
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
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
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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
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