Hypertension, Pulmonary — Endovenous Sildenafil Early Management in Newborns Pulmonary Hypertension
Citation(s)
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.
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. Review.
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. Review.
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. Review.
Martinho S, Adão R, Leite-Moreira AF, Brás-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. Review.
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.
Efficacy and Safety of Endovenous Sildenafil Early Management in Newborns Pulmonary Hypertension: a Clinical Trial
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
