Trial reportPediatric pulmonology2025
The Effect of Chronic Azithromycin Use in Winter on Health Care Utilization for Children With Bronchopulmonary Dysplasia: A Double Blind Randomized Controlled Study (RCT).
Trial report in Pediatric pulmonology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02544984 (The Anti-inflammatory Effect of Prophylactic Macrolides on Children With Chronic Lung Disease), which is not on this map. Not yet cited in PubMed.
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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.
The Anti-inflammatory Effect of Prophylactic Macrolides on Children With Chronic Lung Disease: a Double Blinded RCT
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Authors and funding
18 authors.
Funding
Abstract
backgroundBronchopulmonary dysplasia (BPD), a chronic lung disease in preterm infants, often leads to acute respiratory exacerbations triggered by infections. Our previous mouse study suggested that azithromycin's anti-inflammatory properties may benefit virus-induced respiratory illnesses prophylactically.
methodsIn this single-center, double-blind RCT, 60 children (6 months to 6 years) with BPD received azithromycin (5 mg/kg three times weekly; n = 30) or placebo (n = 30) for one winter season (October to March). Primary outcome was the total number of days of unscheduled healthcare clinic visits, ER visits, and hospital days. Secondary outcomes comprised clinic visits, ER visits, hospital admissions, hospital days, and adverse events. Standard frequentist and Bayesian analyses were used.
resultsNo significant difference in primary outcomes, unscheduled healthcare visits (macrolides 14.9 vs. 4.2 per child-year; p = 0.1, IRR = 2.1; 95% CI: 0.8-5.4), Bayesian analysis showing 11% probability of benefit; however, high-risk children (< 2 years, no tracheostomy), rates were lower with the macrolide group (2.7 vs. 4.6 per child-year; IRR = 0.6; 95% CI: 0.2-1.5), with an 82% probability of benefit. Two outliers in the macrolide group stayed > 40 days in the hospital for non-medical reasons. For secondary outcomes, we observe a decrease in the intervention group on ER visits (0.5 vs. 1.3 per child-year; p = 0.047, IRR = 0.4; 95% CI: 0.1-0.9). Hospital days increased (12.1 vs. 1.2 per child-year; IRR = 9.3; 95% CI: 5.5-16.8).
conclusionsMacrolide prophylaxis did not lead to a significant reduction in the primary outcome of unscheduled healthcare encounter days, but subgroup analysis suggests a potential benefit in high-risk children, with 82% probability of benefit.
trial registrationNCT02544984.
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