Endovenous Sildenafil Early Management in Newborns Pulmonary Hypertension

Summary

Sildenafil is currently approved for the management of pulmonary hypertension of the newborn, with the availability of intravenous presentation it has been seen that the severity condition has already established, many times these patients do not have the adequate clinical response and there are no studies to date that evaluate the efficacy and safety of the same when it is started early in these patients, therefore we plan a randomized clinical trial to determine the efficacy and safety of the administration of intravenous sildenafil for early management of newborns with persistent pulmonary hypertension of the newborn.

Timeline

Start

2025-01-01

Primary completion

2026-06-15

Completion

2026-12-30

Publications

• Background Martinho S, Adao R, Leite-Moreira AF, Bras-Silva C. Persistent Pulmonary Hypertension of the Newborn: Pathophysiological Mechanisms and Novel Therapeutic Approaches. Front Pediatr. 2020 Jul 24;8:342. doi: 10.3389/fped.2020.00342. eCollection 2020.
• Background Jain A, McNamara PJ. Persistent pulmonary hypertension of the newborn: Advances in diagnosis and treatment. Semin Fetal Neonatal Med. 2015 Aug;20(4):262-71. doi: 10.1016/j.siny.2015.03.001. Epub 2015 Apr 2.
• Background Fuloria M, Aschner JL. Persistent pulmonary hypertension of the newborn. Semin Fetal Neonatal Med. 2017 Aug;22(4):220-226. doi: 10.1016/j.siny.2017.03.004. Epub 2017 Mar 23.
• Background Baquero H, Soliz A, Neira F, Venegas ME, Sola A. Oral sildenafil in infants with persistent pulmonary hypertension of the newborn: a pilot randomized blinded study. Pediatrics. 2006 Apr;117(4):1077-83. doi: 10.1542/peds.2005-0523.
• Background Pedersen J, Hedegaard ER, Simonsen U, Kruger M, Infanger M, Grimm D. Current and Future Treatments for Persistent Pulmonary Hypertension in the Newborn. Basic Clin Pharmacol Toxicol. 2018 Oct;123(4):392-406. doi: 10.1111/bcpt.13051. Epub 2018 Jul 19.
• Background Lakshminrusimha S, Mathew B, Leach CL. Pharmacologic strategies in neonatal pulmonary hypertension other than nitric oxide. Semin Perinatol. 2016 Apr;40(3):160-73. doi: 10.1053/j.semperi.2015.12.004. Epub 2016 Jan 14.
• Background El-Khuffash A, McNamara PJ, Breatnach C, Bussmann N, Smith A, Feeney O, Tully E, Griffin J, de Boode WP, Cleary B, Franklin O, Dempsey E. The use of milrinone in neonates with persistent pulmonary hypertension of the newborn - a randomised controlled trial pilot study (MINT 1): study protocol and review of literature. Matern Health Neonatol Perinatol. 2018 Dec 3;4:24. doi: 10.1186/s40748-018-0093-1. eCollection 2018.
• Background Uslu S, Kumtepe S, Bulbul A, Comert S, Bolat F, Nuhoglu A. A comparison of magnesium sulphate and sildenafil in the treatment of the newborns with persistent pulmonary hypertension: a randomized controlled trial. J Trop Pediatr. 2011 Aug;57(4):245-50. doi: 10.1093/tropej/fmq091. Epub 2010 Oct 4.

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