ArticleTrials2026
High-flow nasal cannula versus continuous positive airway pressure for initial respiratory support in very preterm infants: study protocol for a multicenter randomized controlled trial (SIMPLSAFE3).
Article in Trials, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06543589 (A Randomised Trial Comparing of High Flow Nasal Cannula Versus Cpap for Initial Respiratory Stabilisation of Very Premature Infants), 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
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A Randomised Trial Comparing of High Flow Nasal Cannula Versus Cpap for Initial Respiratory Stabilisation of Very Premature Infants
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Authors and funding
5 authors.
Funding
Abstract
backgroundNon-invasive continuous positive airway pressure (CPAP) is the standard initial respiratory support for preterm infants. However, requirements such as optimal pressure delivery and facemask repositioning, which trigger unwanted reflexes and bradycardia, often necessitate the use of positive pressure ventilation (PPV). Findings from a pilot study suggested that high-flow nasal cannula (HFNC) may be a promising alternative to CPAP, with lower PPV requirements. We hypothesize that HFNC is a safe, effective, and user-friendly alternative to CPAP for stabilizing very preterm infants (28 + 0-31 + 6 weeks of gestation), potentially reducing the need for PPV. We aim to compare HFNC and CPAP as initial respiratory support strategies at birth.
methodsThis is a multicenter, randomized, stepped-wedge cluster trial. Infants will receive either HFNC (8 L/min) or CPAP (6 cmH DISCUSSION: The findings may inform future respiratory support guidelines for very preterm infants at birth.
trial registrationClinicalTrials.gov NCT06543589. Registered on August 9, 2024.
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