Trial reportJournal of perinatology : official journal of the California Perinatal Association2017
Inhaled hydrofluoalkane-beclomethasone dipropionate in bronchopulmonary dysplasia. A double-blind, randomized, controlled pilot study.
Trial report in Journal of perinatology : official journal of the California Perinatal Association, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 5 of them syntheses that pooled it.
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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
9 citing papers in PubMed, 5 syntheses or guidelines pooled it, 17 citations in OpenAlex.
- Late (≥ 7 days) inhaled corticosteroids to reduce bronchopulmonary dysplasia in preterm infants.The Cochrane database of systematic reviews · 2022Pooled it
- Outpatient Respiratory Management of Infants, Children, and Adolescents with Post-Prematurity Respiratory Disease: An Official American Thoracic Society Clinical Practice Guideline.American journal of respiratory and critical care medicine · 2021Guideline
- Eligibility Criteria and Representativeness of Randomized Clinical Trials That Include Infants Born Extremely Premature: A Systematic Review.The Journal of pediatrics · 2021Pooled it
- Airway administration of corticosteroids for prevention of bronchopulmonary dysplasia in premature infants: a meta-analysis with trial sequential analysis.BMC pulmonary medicine · 2017Pooled it
- Late (≥ 7 days) inhalation corticosteroids to reduce bronchopulmonary dysplasia in preterm infants.The Cochrane database of systematic reviews · 2017Pooled it
- Steroid Use for Established Bronchopulmonary Dysplasia: A Systematic Review and Meta-Analysis.Children (Basel, Switzerland) · 2025Review
- Tracheomalacia Reduces Aerosolized Drug Delivery to the Lung.Journal of aerosol medicine and pulmonary drug delivery · 2024Article
- Summary for Clinicians: Clinical Practice Guidelines for Outpatient Respiratory Management of Infants, Children, and Adolescents with Post-Prematurity Respiratory Disease.Annals of the American Thoracic Society · 2022Article
- Efficacy of glucocorticoids, vitamin A and caffeine therapies for neonatal mortality in preterm infants: a network meta-analysis.Oncotarget · 2017Article
Corrections and comments
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Authors and funding
9 authors at 6 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveThe efficacy of inhaled steroids in spontaneously breathing infants with established bronchopulmonary dysplasia (BPD) is debatable. The inhaled steroid hydrofluoalkane-beclomethasone dipropionate (QVAR) is unique in its small particle size that results in higher lung deposition. Our objective was to determine if inhaled QVAR could decrease respiratory rehospitalizations of infants with established BPD. STUDY
designDouble-blind, randomized placebo-controlled, multicenter pilot study. Preterm infants with moderate-to-severe BPD were randomized to inhaled QVAR 100 μg per dose or placebo twice daily via Aerochamber with face mask. Treatment was administered daily from recruitment at 36 weeks post menstrual age until 3 months post discharge. Analysis was carried out by intention to treat.
resultsThe QVAR (n=18) and placebo (n=20) groups were comparable in birth and recruitment characteristics. Length of stay (108.5±26.3 vs 108.7±36.0 days) and infants requiring oxygen at discharge (5/17 vs 6/19) or at study end (0/17 vs 2/19) were comparable. Respiratory rehospitalizations/infant (0.1±0.5 vs 0.4±0.6), rehospitalization days (0.5±1.5 vs 4.1±10.3), and post-discharge additive inhaled (0.3±0.9 vs 6.4±21.5 days), systemic (0.7±2.8 vs 1.0±1.4 days) and combined (inhaled/systemic) steroids (1.0±2.9 vs 7.8±25.8 days) tended to be lower in the QVAR compared with the placebo group. Blood pressure, height and weight gain, and urine cortisol/creatinine ratio at study end were comparable between groups.
conclusionsOur study was unable to detect a significant effect of inhaled QVAR on the respiratory course of established BPD. The study was underpowered. Possible benefits of QVAR could be masked by a tendency toward higher use of additional steroids in the placebo group.
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