Status:
COMPLETED
A Non-Interventional Follow Up Study For Subjects Who Received Sildenafil for Persistent Pulmonary Hypertension of the Newborn (PPHN)
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Pulmonary Hypertension, Persistent, of the Newborn
Eligibility:
All Genders
Up to 1 years
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 s...
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.
Eligibility Criteria
Inclusion
- Any subject who received sildenafil treatment in study A1481276.
- Signed and dated informed consent document by legal guardian.
Exclusion
- Any subject who did not receive sildenafil treatment during study A1481276.
Key Trial Info
Start Date :
November 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01801982
Start Date
November 1 2012
End Date
December 1 2013
Last Update
February 1 2021
Active Locations (1)
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1
Great Ormond Street Hospital, Paediatric Intensive Care
London, United Kingdom, WC1N 3JH