Overview

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