1. The use of high-flow nasal cannulae was noninferior to the use of nasal CPAP according to a pre-specified margin of noninferiority.
2. The incidence of nasal trauma was significantly lower in the nasal-cannulae group than in the CPAP group.
Evidence Rating Level: 1 (Excellent)
Study Rundown: In this multicenter, randomized, noninferiority trial, the authors found that the use of high-flow nasal cannulae was noninferior to nasal continuous positive airway pressure (CPAP) for very preterm infants (gestational age <32 weeks) after extubation. High-flow nasal cannulae have become increasingly popular for non-invasive respiratory support in neonatal intensive care units around the world. This is due to purported advantages which include a simpler interface, making nasal cannulae more comfortable for the infant and more conducive to mother-infant bonding in comparison to CPAP. Despite the widespread adoption of this technique, few studies have specifically investigated the safety, efficacy, risks, and benefits of this new technique compared to the current standard of care.
This study’s results provide support for the ongoing use of high-flow nasal cannulae for very preterm infants after extubation, given that this method was found to be noninferior to nasal CPAP. Furthermore, the authors provide grounding for the notion that nasal cannulae cause fewer cases of nasal trauma compared to CPAP. Strengths of this study include its randomized study design and the fact that its short duration (following infants for a primary outcome of treatment failure within 7 days of extubation) allowed for very high compliance in both treatment arms. Drawbacks of the study include the arbitrary choice for a prespecified margin of noninferiority (20% above the failure rate for nasal CPAP) and the fact that the primary outcome measure had an upper limit of the confidence interval that was close to the prespecified cutoff value. This suggests that a small difference in the outcomes could have prevented a conclusion of noninferiority. Also, the study was underpowered to show noninferiority in infants with a gestational age of less than 26 weeks; additional research will be required to investigate use of high-flow nasal cannulae in this specific population.
In-Depth [randomized, controlled trial]: This trial randomly assigned 303 preterm infants to receive high-flow nasal cannulae or nasal CPAP following extubation. Infants were eligible if they were born at a gestational age of less than 32 weeks, were receiving mechanical ventilation via endotracheal tube, and were scheduled to undergo extubation for the first time to noninvasive respiratory support. There were no significant differences between treatment groups on a number of demographic and process measures including administration of surfactant, caffeine, and exposure to antenatal steroids. The primary outcome measure was short-term treatment efficacy; analyses were performed on an intention-to-treat basis, and infants remained in their assigned treatment group in all cases.
The use of high-flow nasal cannulae was found to be noninferior to the use of nasal CPAP. Treatment failure occurred in 34.2% of infants in the nasal-cannulae group and 25.8% of infants in the CPAP group (risk difference, 8.4%; 95% CI, -1.9 to 18.7). Noninferiority was determined based on a prespecified margin of 20%, meaning that the upper limit of the 95% confidence interval had to be below 20% and the lower limit of the same interval had to be below zero. A secondary outcome was the percentage of infants who underwent reintubation within 7 days after extubation. In this case, the risk difference was -7.4% (95% CI, -16.6 to 1.8, p=0.12) for nasal cannulae versus CPAP. The lower rate of reintubation in the nasal cannulae group was attributed in part to the fact that these patients were allowed to undergo nasal CPAP in the event of treatment failure where as patients assigned to CPAP were immediately reintubated upon treatment failure. Only 17.8% of infants in the nasal-cannulae group were reintubated compared to 25.2% of those in the CPAP group. Finally, infants in the nasal-cannulae group had a significantly lower rate of nasal trauma than those in the CPAP group (39.5% vs. 54.3%, p=0.01).
By Matthew Growdon and Adrienne Cheung
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