Copyright: ©Author(s) 2026. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution-NonCommercial (CC BY-NC 4.0) license. No commercial re-use. See permissions. Published by Baishideng Publishing Group Inc.
World J Clin Pediatr. Sep 9, 2026; 15(3): 118862
Published online Sep 9, 2026. doi: 10.5409/wjcp.118862
Published online Sep 9, 2026. doi: 10.5409/wjcp.118862
Vardenafil efficacy for the treatment of persistent pulmonary hypertension of the newborn
Sania El-Hindi, Pediatric Cardiology, Children’s Hospital, Damascus University, Dimashq 011, Syria
Author contributions: El-Hindi S had primary responsibility for protocol development, patient screening, enrollment, outcome assessment, preliminary data analysis and writing the manuscript.
Institutional review board statement: The research was approved by the Ethical Review Board of Damascus University in January 2023 (No. MD 116/1800).
Clinical trial registration statement: The research was approved by the scientific research board of Damascus University in April 2023. Also registered on clinical trials registry. Clinicaltrials.gov identifier: NCT06860399.
Informed consent statement: Written informed consent was obtained from guardians prior to treatment initiation for participation and publication of the data.
Conflict-of-interest statement: No competing interests to disclose.
CONSORT 2010 statement: The author has read the CONSORT 2010 statement, and the manuscript was prepared and revised according to the CONSORT 2010 statement.
Data sharing statement: Data sets analyzed in this study are not publicly available, but can be shared with researchers upon a reasonable request.
Corresponding author: Sania El-Hindi, Pediatric Cardiology, Children’s Hospital, Damascus University, Mazzeh, Damascus 011, Syria. saniahindi@yahoo.com
Received: January 13, 2026
Revised: February 13, 2026
Accepted: April 3, 2026
Published online: September 9, 2026
Processing time: 200 Days and 8.9 Hours
Revised: February 13, 2026
Accepted: April 3, 2026
Published online: September 9, 2026
Processing time: 200 Days and 8.9 Hours
Core Tip
Core Tip: This is the first randomized controlled trial to evaluate the efficacy of vardenafil in the management of patients with persistent pulmonary hypertension of the newborn (PPHN). The study demonstrated that improvements in pulmonary hypertension, pulmonary vascular resistance, pulmonary artery flow velocity, and respiratory distress were faster in the vardenafil group than in sildenafil group without adverse events. These findings if confirmed in larger clinical trials may position vardenafil as a preferred first-line therapy for PPHN particularly in resource limited settings.