1. Preterm infants receiving primary respiratory support had treatment failure at a significantly higher rate when treated with nasal high-flow therapy as compared with continuous positive airway pressure (CPAP).
2. Adverse events observed in both treatment groups were generally similar, though preterm infants treated with nasal high-flow therapy experienced a lower rate of nasal trauma.
Evidence Rating: 1 (Excellent)
Study Rundown: Preterm infants are at an elevated risk for respiratory complications. Respiratory support improves outcomes for many preterm infants, though adverse complications can result from more invasive supportive measures like endotracheal ventilation. Effective noninvasive respiratory support methods are therefore used as first line measures, with the possibility of moving to more invasive techniques if necessary. In this study nasal high-flow therapy is tested to assess if it is noninferior to CPAP as primary ventilatory support.
Preterm infants of gestational age 28 weeks to 36 weeks and 6 days, less than 24 hours old, and in need of noninvasive respiratory support were included in this study. Infants were stratified by those greater than 32 weeks and less than 32 weeks before randomization. The newborns were then placed on either high-flow therapy or CPAP until therapy was no longer deemed clinically necessary or the patient failed treatment. Patients in the high-flow group were placed on CPAP and then mechanical ventilation, respectively, if treatment failed, while those failing CPAP went straight to mechanical ventilation. Adverse events resultant from ventilatory support were recorded until either discharge home or patient death. Patients in the nasal high-flow therapy group failed treatment significantly more than those supported with CPAP in the first 72 hours after birth. Infants in both gestational age groups were significantly more likely to fail nasal high-flow therapy. The study was prematurely ended once this data was established. Differences in adverse events were not observed between the two groups, with the exception of nasal trauma being more likely in infants treated with CPAP.
Click to read the study, published today in NEJM
Relevant Reading: Nasal high-flow therapy delivers low level positive airway pressure
In-Depth [randomized controlled trial]: Newborn patients from 9 intensive care units in Australia and Norway from 2013 to 2015 were included in this study. The study was originally designed to include 750 infants to show noninferiority of nasal high-flow therapy compared to CPAP as the primary respiratory support, though it ended after 583 infants were recruited. Of those, 564 were eligible to be included in the analysis (n = 278 in high-flow group, n = 286 in CPAP group). Infants between gestational ages of 28 weeks and 36 weeks and 6 days, less than 24 hours old, had not been intubated or received surfactant treatment, and in need of respiratory support were eligible for the study. Randomization of treatment was done after patients were stratified by gestational age (>32 weeks and <32 weeks). All infants <1.25 kg were treated with caffeine. High-flow therapy was performed at 6-8 L/min, and CPAP at pressures of 6-8 cm of water. Infants were treated until not clinically necessary or treatment failure. Treatment failure was defined as the patient on max ventilatory setting and a high fraction of inspired oxygen (0.4+), a low pH (<7.2) and high ppCO2 (60+ mm Hg), or requiring further ventilatory support.
The nasal high-flow therapy group failed treatment at a significantly higher rate than the CPAP group within 72 hours of birth (25.5% vs 13.3%, p < 0.001). Infants born at greater than 32 weeks of gestation failed high-flow therapy compared to the CPAP group (32.9% vs. 18.1%; 95% CI 4.8 to 24.7, p = 0.004). A similar outcome was observed in the lower then 32 week group as well (18.1% vs. 8.0%, 95%CI 2.2 to 18.0, p = 0.01). Treatment failure due to urgent need for intubation occurred more frequently in the CPAP group (18.4% vs. 5.6%, p = 0.03). Nasal trauma was more likely in infants treated with CPAP (8.3% vs 18.5%, p < 0.001), while no other rate for adverse events differed between the two groups.
Image: PD
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