Summary: A randomized pilot study comparing heated humidified high-flow nasal cannulae with NIPPV for RDS

Topic: Primary Support – NICU

Kugelman, A, Riskin, A, Said, W, et al. A randomized pilot study comparing heated humidified high-flow nasal cannulae with NIPPV for RDS. Pediatr Pulmonology, 2015; 50(6): 576-583. 

Dr. Kugelman and colleagues evaluated the efficacy of Vapotherm high velocity therapy against nasal intermittent positive pressure ventilation (NIPPV) as a primary support modality (not following extubation) in preterm infants. They hypothesized that both modalities give a comparable level of support and studied infants <35 weeks gestation but >1,000g. High velocity therapy was administered with flows up to 5 L/min using Vapotherm nasal prongs such that the prongs were no larger than ½ the diameter of the nares. NIPPV is a bi-level pressure support provided to infants via nasal interface, similar to non-invasive ventilation in adults provided by way of a mask. The primary outcome for this trial was the need for intubation, with secondary outcomes related to clinical features during therapy and relevant clinical outcomes. Among 76 infants with comparable characteristics, 38 in each group, the need for endotracheal intubation was not different (high velocity therapy = 29% vs. NIPPV = 34%, p = 0.80). Among infants who were intubated, arterial CO2 tension was higher (64.0 vs. 48.9 mmHg, P = 0.01), and arterial pH was lower (7.21 vs. 7.28, P = 0.04) prior to mechanical ventilation on NIPPV versus high velocity therapy, demonstrating a more pronounced ventilation effect for high velocity therapy. There was no difference in clinical outcomes including air leak, nasal trauma, and development of chronic lung disease. The time to end nasal support was longer for high velocity therapy compared to NIPPV (2 vs 4 days; p = 0.006), but with no difference in length of stay. 

The study limitations are that the mode of support assignment could not be blinded to the medical team; however, objective failure criteria and management protocols were used to reduce the possibility of a bias that this might have caused. In addition, this was a pilot study, as high velocity therapy was never used before as initial therapy of respiratory distress syndrome (RDS). The authors based the power calculation on a previous study, but the actual rate of intubation in the current study was lower. Thus, the authors note it is possible that the study was underpowered. The sample size of the study population may not have been large enough to completely rule out a beneficial effect of either mode of nasal support. The study was powered for superiority, but equivalence was found. The study was limited to infants > 1,000 g for safety reasons. Thus, there was a small sample size for infants < 1,500 g , so the study results in these infants should be interpreted with caution. In addition, the safety conclusions should be taken with caution as the study did not have sufficient statistical power to detect differences in relatively infrequent complications such as air leak, necrotizing enterocolitis, patent ductus arteriosus intraventricular hemorrhage.  

The authors conclude that high velocity therapy may be as effective as NIPPV in preventing endotracheal ventilation in the initial treatment of RDS in premature infants <35 weeks GA and with BW >1,000g, and found that the rates of neonatal morbidities were comparable in both modes of non-invasive respiratory support. The authors discuss that the difference in length of time on nasal support could be related to the perception of the therapy. They state, “Infants on NIPPV are perceived to be “ventilated” and may be weaned more aggressively to avoid nasal trauma and discomfort (a possible bias for the different length of non-invasive respiratory support).” The authors note that the pilot study provides the basis for further, larger prospective, randomized trials before it can be concluded that high velocity therapy is safe and can serve as primary mode of non-invasive respiratory support in premature infants with RDS. 

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CAUTION: US Federal law restricts this device to sale by or on the order of a physician. Indications, contraindications, warnings, and instructions for use can be found in the product labelling supplied with each device or at https://vapotherm.com/resources/support/precision-flow-reference/. For spontaneously breathing patients. High Velocity Therapy (HVT) does not provide total ventilatory requirements of the patient. It is not a ventilator. Decisions surrounding patient care depend on the physician’s professional judgment in consideration of all available information for the individual case, including escalation of care depending on patient condition.