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Safety of Sildenafil in Premature Infants — SIL02  

Bronchopulmonary Dysplasia Clinical Trial

Official title:
Safety of Sildenafil in Premature Infants at Risk of Bronchopulmonary Dysplasia

Clinical Trial 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.

Clinical Trial Description

This will be a multi-center, randomized, placebo-controlled, sequential dose escalating, double masked, safety data study of sildenafil in premature infants. This is a Phase II study design, premature infants (inpatient in neonatal intensive care units) will be randomized in a dose escalating approach 3:1 (sildenafil: placebo) into 3 cohorts with escalating doses of sildenafil. There will be 40 randomized and dosed participants in each cohort for a total of up to 120 participants. Cohort 1 sildenafil dose will be 0.125 mg/kg q 8 hours IV or 0.25 mg/kg q 8 hours enteral. Cohort 2 sildenafil dose will be 0.5 mg/kg q 8 hours IV or 1.0 mg/kg q 8 hours enteral. Cohort 3 sildenafil dose will be 1 mg/kg q 8 hours IV or 2 mg/kg q 8 hours enteral. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03142568
Study type Interventional
Source University of North Carolina, Chapel Hill
Contact Matthew M Laughon, MD, MPH
Phone 984-974-7851
Email matt_laughon@med.unc.edu
Status Recruiting
Phase Phase 2
Start date April 2, 2018
Completion date March 2025
View Details
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