Safety of Sildenafil in Premature Infants

About the Study

Currently Recruiting: Participants

Study Drug/Intervention: Sildenafil or Placebo

Study Timeline: This study is expected to conclude in September 2024. 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 & Exclusion Criteria

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

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