SIL02

Currently Recruiting: Participants

Study Drug/Intervention: Sildenafil or Placebo

Study Timeline: This study is expected to conclude in December 2024.

ClinicalTrials.gov ID: NCT03142568

Study Objectives

Describe the safety of sildenafil in premature infants at risk of bronchopulmonary dysplasia and determine preliminary effectiveness and pharmacokinetics (PK) of sildenafil.

Inclusion Criteria:

• Receiving positive airway pressure (nasal continuous airway pressure, nasal intermittent positive pressure ventilation, or nasal cannula flow > 1LPM) or mechanical ventilation (high frequency or conventional)
• <29 weeks gestational age at birth
• 7-28 (inclusive) days postnatal age at time of randomization

Exclusion Criteria:

• Currently receiving vasopressors
• Currently receiving inhaled nitric oxide
• Baseline mean arterial pressure < gestational age (in weeks) plus postnatal age (in weeks) within 2 hours of sildenafil administration
• Known allergy to sildenafil
• Known sickle cell disease
• AST > 225 U/L < 72 hours prior to randomization
• ALT > 150 U/L < 72 hours prior to randomization

FDA Office of Orphan Products Development

• PI: Matthew M Laughon, MD, MPH
• PL: Talaya McCright-Gill, MA