Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

Safety of Sildenafil in Premature Infants at Risk of Bronchopulmonary Dysplasia

ID
Name
17-2436
Description
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.
Trial arms
Trial start
2018-04-02
Estimated PCD
2025-02-01
Trial end
2025-03-01
Status
Recruiting
Phase
Early phase I
Treatment
Sildenafil
Infants will be randomized using a 3:1 scheme to receive sildenafil or placebo.
Arms:
Sildenafil cohort 1, Sildenafil cohort 2, Sildenafil cohort 3
Other names:
Revatio
Placebo
Infants randomized to the placebo group will receive the equivalent volume of dextrose 5% for IV use or enteral use (if receiving enteral study drug).
Arms:
Placebo cohort 1, Placebo cohort 2, Placebo cohort 3
Other names:
sugar water
Size
120
Primary endpoint
Safety as determined by adverse event experienced by participants
42 days for each participant
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}
Updated at
2024-05-31

1 organization

1 product

1 indication

Organization
University of North Carolina, Chapel Hill
Product
Sildenafil
Indication
Bronchopulmonary Dysplasia