Autor: |
Jason E. Lang, Chi D. Hornik, Karen Martz, Juliana Jacangelo, Ravinder Anand, Rachel Greenberg, Christoph Hornik, Kanecia Zimmerman, P. Brian Smith, Daniel K. Benjamin, Matthew Laughon |
Jazyk: |
angličtina |
Rok vydání: |
2022 |
Předmět: |
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Zdroj: |
Contemporary Clinical Trials Communications, Vol 30, Iss , Pp 101025- (2022) |
Druh dokumentu: |
article |
ISSN: |
2451-8654 |
DOI: |
10.1016/j.conctc.2022.101025 |
Popis: |
Bronchopulmonary dysplasia (BPD) is a disease of chronic respiratory insufficiency stemming from premature birth and iatrogenic lung injury leading to alveolar simplification, impaired alveolar-capillary development, interstitial fibrosis, and often pulmonary hypertension. BPD is the most common pulmonary sequela of prematurity and is often fatal; however, there remains no FDA-approved therapies to treat or prevent BPD. Sildenafil is increasingly used off-label in premature infants despite scant safety and efficacy data. Sildenafil reduces lung injury and preserves normal vasculature in preclinical models, and improves outcomes in children with pulmonary hypertension, and thus is a promising candidate for BPD. Following phase I studies, we developed the phase II SIL02 trial to describe the safety, pharmacokinetics and preliminary effectiveness of intravenous and enteral sildenafil in premature infants at risk for BPD. SIL02 is a randomized, double-blind, placebo-controlled, 3-cohort, sequential dose-escalating trial of enteral or intravenous (IV) sildenafil dosed every 8 h for up to 34 days. The target IV doses were 0.125, 0.5 and 1 mg/kg/dose in cohorts 1, 2 and 3, respectively; while the enteral doses will be double the IV doses. Eligible infants must be |
Databáze: |
Directory of Open Access Journals |
Externí odkaz: |
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