Grants and Contracts Details
HUMAN CLINICAL TRIAL Determining the safety of sildenafil in premature infants is an urgent, unmet public health need. Investigating sildenafil represents an ideal opportunity to approach the problem of the research gap of drugs in premature infants because: 1) Premature infants with BPD often die or have life-long problems; 2) There are no drugs that are FDA indicated for preventing BPD; and 3) Preventing mortality and morbidities associated with premature birth has life-long benefits. Primary: Describe the safety of sildenafil in premature infants at risk of BPD Secondary: Preliminary effectiveness and pharmacokinetics (PK) of sildenafil Study Design: Multi-center, randomized, placebo-controlled, sequential dose escalating, double masked, safety study Inclusion Criteria 1. Documented informed consent from parent or guardian, prior to study procedures 2. 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) at the time of randomization* 3. 225 U/L < 72 hours prior to randomization* 9. ALT > 150 U/L < 72 hours prior to randomization* 10. Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study* *Participant will be re-assessed prior to dosing to reconfirm
|Effective start/end date||8/13/19 → 9/30/22|
- Duke University: $28,900.00
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