Trial reportClinical drug investigation2019
Prophylactic Sildenafil in Preterm Infants at Risk of Bronchopulmonary Dysplasia: A Pilot Randomized, Double-Blinded, Placebo-Controlled Trial.
Trial report in Clinical drug investigation, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
10 citing papers in PubMed, 2 syntheses or guidelines pooled it, 16 citations in OpenAlex.
- Efficacy of pharmacologic therapies for reducing bronchopulmonary dysplasia and mortality in preterm infants: a network meta-analysis.BMC pediatrics · 2026Pooled it
- Eligibility Criteria and Representativeness of Randomized Clinical Trials That Include Infants Born Extremely Premature: A Systematic Review.The Journal of pediatrics · 2021Pooled it
- Variable clinical and hemodynamic effect of sildenafil in extreme premature infants with bronchopulmonary dysplasia-associated pulmonary hypertension.Journal of perinatology : official journal of the California Perinatal Association · 2026Article
- The rationale of using angiotensin receptor blocker instead of pulmonary vasodilators to treat pulmonary hypertension in bronchopulmonary dysplasia: a case report and literature review.Frontiers in pediatrics · 2025Article
- Efficacy of Sildenafil in Infants with Bronchopulmonary Dysplasia-Associated Pulmonary Hypertension.Children (Basel, Switzerland) · 2023Article
- Early diagnosis and targeted approaches to pulmonary vascular disease in bronchopulmonary dysplasia.Pediatric research · 2022Review
- Pharmacotherapy in Bronchopulmonary Dysplasia: What Is the Evidence?Frontiers in pediatrics · 2022Review
- The feasibility of ultrasound Graf method in screening infants and young children with congenital hip dysplasia and follow-up of treatment effect.Translational pediatrics · 2021Article
- Update on the use of sildenafil in neonatal pulmonary hypertension: a narrative review of the history, current administration, and future directions.Translational pediatrics · 2021Review
- Use of Oral Sildenafil in the Management of Persistent Pulmonary Hypertension of the Newborn: A Case Report and Review of Literature.Nigerian medical journal : journal of the Nigeria Medical AssociationReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 2 institutions in 1 country.
Funding
Abstract
backgroundBronchopulmonary dysplasia (BPD) is the need for oxygen therapy at 36 weeks postmenstrual age (PMA). Sildenafil has been shown to enhance the lung alveolarization and vascularization in newborn animal models after lung injury and has possible therapeutic potential for the prevention of BPD.
objectiveTo perform a proof-of-concept, Phase II, pilot randomized, double-blind, clinical trial to study the efficacy of sildenafil in preventing BPD, in postnatal (< 24 h), extremely and very preterm infants.
methodsThis Phase II, pilot randomized, double-blind, clinical trial was conducted in the Neonatal Intensive Care Unit of Women's Wellness and Research Center, Doha, Qatar during 2012-2014. Infants of 24
resultsNo significant differences were observed between the sildenafil and placebo study groups in mortality at 36 weeks PMA (10% vs 20%, p = 1), respiratory support at 36 weeks (30% vs 25%, p = 0.57), and side effects (0% vs 0%). For all other secondary outcomes, no significant differences were detected.
conclusionsWhile not associated with side effects, off-label oral sildenafil did not demonstrate benefits in the prevention of BPD or death in the extreme and very preterm infants. Future studies of dosing and efficacy that target different regimens of sildenafil are warranted before sildenafil is recommended for the prevention of BPD.
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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.