Non-Invasive respiratory support during elective intubation in preterm infants-a randomized controlled trial.

BACKGROUND

Neonatal 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.

OBJECTIVE

To 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.

METHODS

This 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.

RESULTS

56 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).

CONCLUSION

Continuing 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.