Safety of Sildenafil in Premature Infants

• Status: Recruiting
• Trial end date: 2022-09-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Duke University; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); The Emmes Company, LLC; The EMMES Corporation
• Treatments: Sildenafil Citrate

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