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

Viatris

Status: Completed

Conditions: Pulmonary Hypertension, Persistent, of the Newborn

Treatments: Other: non-interventional

Study type: Observational

Funder types: Industry

Identifiers

NCT01801982

A1481283

2010-021266-30 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: Under 1 year old

Volunteers: No Healthy Volunteers

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.