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

Tracking Information
First Submitted Date	January 8, 2013
First Posted Date	March 1, 2013
Results First Submitted Date	December 2, 2014
Results First Posted Date	December 10, 2014
Last Update Posted Date	December 10, 2014
Study Start Date	November 2012
Actual Primary Completion Date	December 2013 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: December 2, 2014)	Number of Participants With Physical Examination Abnormalities at Month 12 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Original Primary Outcome Measures; (submitted: February 27, 2013)	Physical Examination (Bayley Neurological Assessments, Ophthalmology Exam, Hearing) [ Time Frame: at 12 months ]; Physical Examination (Bayley Neurological Assessments, Ophthalmology Exam, Hearing) [ Time Frame: at 24 months ]; Medical History, to include clinically relevant hospital admissions [ Time Frame: at 12 months ]; Medical History, to include clinically relevant hospital admissions [ Time Frame: at 24 months ]
Change History	Complete list of historical versions of study NCT01801982 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures; (submitted: December 2, 2014)	Overall Survival at Month 12 [ Time Frame: 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.; Overall Survival at Month 24 [ Time Frame: 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) [ Time Frame: 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.
Original Secondary Outcome Measures; (submitted: February 27, 2013)	Overall Survival (OS) [ Time Frame: at 12 months ]; Overall Survival (OS) [ Time Frame: at 24 months ]
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	A Non-Interventional Follow Up Study For Subjects Who Received Sildenafil for Persistent Pulmonary Hypertension of the Newborn (PPHN)
Official Title	A Follow Up Investigation For Patients Completing Study A1481276 To Investigate Developmental Progress 12 And 24 Months Following Completion Of Sildenafil Treatment
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.
Study Type	Observational
Study Design	Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Pediatric patients who took part in study A1481276 following PPHN treatment with IV sildenafil
Condition	Pulmonary Hypertension, Persistent, of the Newborn
Intervention	Other: non-interventional; non-interventional
Study Groups/Cohorts	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: February 27, 2013)	1
Original Actual Enrollment	Same as current
Actual Study Completion Date	December 2013
Actual Primary Completion Date	December 2013 (Final data collection date for primary outcome measure)
Eligibility Criteria	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	up to 1 Year (Child)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	United Kingdom
Removed Location Countries
Administrative Information
NCT Number	NCT01801982
Other Study ID Numbers	A1481283; 2010-021266-30 ( EudraCT Number )
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Pfizer
Study Sponsor	Pfizer
Collaborators	Not Provided
Investigators	Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account	Pfizer
Verification Date	December 2014