ReviewPediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies2014
Safety of sildenafil in infants*.
Review in Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
19 citing papers in PubMed, 48 citations in OpenAlex.
- Prophylactic Sildenafil in Preterm Infants at Risk of Bronchopulmonary Dysplasia: A Pilot Randomized, Double-Blinded, Placebo-Controlled Trial.Clinical drug investigation · 2019Trial
- Repurposing PDE5-Inhibitors: Sildenafil Drives Arteriogenesis via Localized Regenerative Inflammation.International journal of molecular sciences · 2026Article
- Cardiovascular Sequelae of Bronchopulmonary Dysplasia in Preterm Neonates Born before 32 Weeks of Gestational Age: Impact of Associated Pulmonary and Systemic Hypertension.Journal of cardiovascular development and disease · 2024Review
- Article
- Case Report: Bosentan and Sildenafil Exposure in Human Milk - A Contribution From the ConcePTION Project.Frontiers in pharmacology · 2022Article
- The Role of Sildenafil in Treating Brain Injuries in Adults and Neonates.Frontiers in cellular neuroscience · 2022Review
- Challenges and Pitfalls: Performing Clinical Trials in Patients With Congenital Diaphragmatic Hernia.Frontiers in pediatrics · 2022Review
- Editorial: Perinatal hypoxic-ischemic brain injury: Mechanisms, pathogenesis, and potential therapeutic strategies.Frontiers in cellular neuroscience · 2022Article
- Use of off-label compounded oral sildenafil in the management of persistent pulmonary hypertension of the newborn: A case report.Journal of cardiovascular and thoracic research · 2022Article
- Life-threatening PPHN refractory to nitric oxide: proposal for a rational therapeutic algorithm.European journal of pediatrics · 2021Review
- Pharmacokinetic modeling of intravenous sildenafil in newborns with congenital diaphragmatic hernia.European journal of clinical pharmacology · 2020Article
- Sildenafil Exposure in the Neonatal Intensive Care Unit.American journal of perinatology · 2019Article
- Association between oral sildenafil dosing, predicted exposure, and systemic hypotension in hospitalised infants.Cardiology in the young · 2018Article
- Pharmacokinetics of sildenafil in children with pulmonary arterial hypertension.World journal of pediatrics : WJP · 2017Article
- Sildenafil in Infants and Children.Children (Basel, Switzerland) · 2017Review
- Inhaled sildenafil as an alternative to oral sildenafil in the treatment of pulmonary arterial hypertension (PAH).Journal of controlled release : official journal of the Controlled Release Society · 2017Article
- Sildenafil and retinopathy of prematurity risk in very low birth weight infants.Journal of perinatology : official journal of the California Perinatal Association · 2016Article
- Sildenafil therapy in bronchopulmonary dysplasia-associated pulmonary hypertension: a retrospective study of efficacy and safety.European journal of pediatrics · 2015Article
- Treatment of pulmonary arterial hypertension in children.Nature reviews. Cardiology · 2015Review
Corrections and comments
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Authors and funding
3 authors at 2 institutions in 3 countries.
Funding
Abstract
objectiveIn view of the recent U.S. Food and Drug Administration's warning against the use of sildenafil in pediatric patients, we aimed to provide an updated overview of the dosing and safety of sildenafil in infants and to explore the relevance of the present safety concerns to the infant population. DATA SOURCE: The National Library of Medicine PubMed and Cochrane Database of Systematic Reviews were searched using the following terms: Sildenafil AND (infant OR infants OR newborn OR newborns OR child OR children OR childhood OR pediatric OR pediatrics OR paediatric OR paediatrics). STUDY SELECTION: Studies presenting original clinical data regarding the dosing, use, or safety of sildenafil in infants with pulmonary hypertension would be included. DATA EXTRACTION: Of the 49 included studies, case reports and case series were the most common type of publications (n = 25). The identified trials included 625 children, with more than 140 infants. Persistent pulmonary hypertension of the newborn and pulmonary hypertension associated with other conditions were the most common underlying diagnoses.
conclusionThere is currently no evidence of serious adverse event in infants exposed to sildenafil. Present safety concerns regarding the use of sildenafil in pediatric patients should be further explored before being applied to infant population. Sildenafil remains a valuable option for the treatment of pulmonary hypertension in young infants. Prospective studies should be designed in such a way that they include a safety assessment to evaluate potential adverse outcomes of sildenafil therapy in this population.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.