Trial reportBMC pediatrics2025
Non-Invasive respiratory support during elective intubation in preterm infants-a randomized controlled trial.
Trial report in BMC 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.
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Authors and funding
3 authors.
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Abstract
backgroundNeonatal intubation has a low success rate and can potentially be improved through apneic oxygenation. Previous studies have utilized nasal high-flow therapy during intubation, particularly in preterm infants. Notably, a significant proportion of neonates requiring intubation are already receiving non-invasive respiratory support modalities, including non-invasive positive pressure ventilation (NIPPV) or continuous positive airway pressure (CPAP). The feasibility of maintaining non-invasive ventilation during the intubation process in newborns has not been thoroughly investigated, despite its potential physiological benefits.
objectiveTo evaluate the feasibility, safety, and efficacy of non-invasive ventilation through a soft nasal cannula during preterm infant intubation. The primary outcome was successful intubation on the first attempt without physiological instability, defined as a ≥ 20% decrease in arterial oxygen saturation or a heart rate < 100/min.
methodsThis unblinded parallel-group randomized controlled trial was conducted in a neonatal unit in eastern India between January and December 2024. Eligible preterm infants on NIPPV or CPAP requiring elective intubation were randomly assigned to one of two groups: the intervention group, which maintained pre-existing respiratory support via an Opti Flow junior nasal cannula during intubation, or the control group, which underwent the procedure without any respiratory assistance. The ventilatory settings remained unchanged in the intervention group, except that FiO2 could be increased to maintain SpO2.
results56 intubations were randomized into each group. First-attempt successful intubation without physiological instability was significantly lower in the control group (16/56 (28.57%) vs. 29/56 (51.79%), p = 0.021). Absolute risk reduction was 23.23% favoring intervention arm with the number needed to treat for one additional benefit was 5 [-]. The intervention demonstrated greater efficacy in infants weighing ≤ 1000 g and with a SpO2/FiO2 ratio < 1.5 at intubation. Furthermore, the intervention reduced desaturation rates (39.19% vs. 64.10%, p = 0.003), extended time to desaturation (29 vs. 20 s, p = 0.004), and shortened desaturation (7 vs. 9 s, p = 0.006) and bradycardia durations (6 vs. 8 s, p = 0.017).
conclusionContinuing pre-existing non-invasive respiratory support through a soft nasal cannula during intubation enhances first-attempt success rates without inducing physiological instability. TRIAL REGISTRATION NUMBER: CTRI/2023/12/060931.
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