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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Hypertension, Persistent, of the Newborn
• Intervention / Treatment: Other: non-interventional

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
• Enrollment (Actual): 1

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, WC1N 3JH
    • Great Ormond Street Hospital, Paediatric Intensive Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients who took part in study A1481276 following PPHN treatment with IV sildenafil

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: January 8, 2013
• First Submitted That Met QC Criteria: February 27, 2013
• First Posted (Estimate): March 1, 2013

Study Record Updates

• Last Update Posted (Actual): February 1, 2021
• Last Update Submitted That Met QC Criteria: January 28, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: PPHN; development progress after PPHN; developmental progress after sildenafil.
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: A1481283; 2010-021266-30 (EudraCT Number)