Trial reportEuropean journal of pediatrics2025
Higher (40%) versus lower (30%) FiO
Trial report in European journal of pediatrics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The optimal FiO₂ threshold for surfactant administration in preterm neonates with respiratory distress syndrome (RDS) remains uncertain, with limited evidence supporting current guideline recommendations. The objective was to compare the total duration of respiratory support between two FiO₂ thresholds for surfactant administration in preterm neonates stabilized on CPAP. In this non-inferiority randomized control trial (RCT), preterm neonates (26-32 weeks' gestation) with RDS were randomized at 1 h of life to receive surfactant at FiO₂ thresholds of either 40% or 30%. The primary outcome was total duration of respiratory support. The secondary outcomes were requirement of surfactant within 6 h after birth, requirement of repeat dose of surfactant, common morbidities of prematurity bronchopulmonary dysplasia (BPD) stage ≥ 2, air leaks, hemodynamically significant patent ductus arteriosus (hsPDA) (requiring treatment), all-cause mortality, and total duration of hospital stay. Subgroup analysis for gestation between 26 and 29 weeks was done. A total of 205 neonates with a mean birth weight of 1237.92 ± 328.89 g and a mean gestation age of 30.06 ± 1.85 weeks were enrolled. The mean duration of respiratory support was 140.8 h in 40% FiO
conclusionThis first randomized controlled trial directly comparing FiO₂ thresholds of 40% versus 30% for surfactant administration in preterm infants (26-32 weeks) found the higher threshold to be non-inferior, with comparable respiratory and clinical outcomes. The use of a 40% threshold significantly reduced surfactant exposure without increasing complications, supporting its role as a safe and cost-effective strategy for resource-limited settings.
trial registrationCTRI/2023/12/060562. WHAT IS KNOWN: • Early surfactant administration improves outcomes in preterm neonates with RDS. • International guidelines generally recommend a FiO₂ threshold of 30% for surfactant therapy. WHAT IS NEW: • This is the first randomized controlled trial directly comparing FiO₂ thresholds of 40% versus 30% for surfactant administration. • A 40% threshold was non-inferior to 30% in preterm infants (26-32 weeks) without an increase in adverse outcomes, and thus has the potential to support cost effective neonatal care in resource-limited settings and reduce NICU workload. .
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