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Summary: Heated, Humidified High-Flow Nasal Cannula vs Nasal Continuous Positive Airway Pressure for Respiratory Distress Syndrome of Prematurity: A Randomized Clinical Noninferiority Trial
Topic: Primary Support – NICU
By Lavizzari A, Colnaghi M, Ciuffini F, et al. JAMA Pediatr. 2016 Aug 8. doi: 10.1001/jamapediatrics.2016.1243. Lavizzari A, Colnaghi M, Ciuffini F, Veneroni C, Cortinovis I, Musumeci S, Mosca F.
Lavizarri and colleagues demonstrated that heated, humidified high-flow nasal cannula (HHHFNC) using Vapotherm–Precision Flow Hi-VNI® Technology, showed efficacy and safety similar to those of nasal continuous positive airway pressure (nCPAP) or bilevel nCPAP (BiPAP) when applied as a primary approach to mild to moderate respiratory distress syndrome (RDS) in preterm infants older than 28 weeks’ GA. The 2016 study published in JAMA Pediatrics was a randomized clinical noninferiority trial which enrolled 316 infants at a tertiary neonatal intensive care unit who either received High Velocity Nasal Insufflation (HVNI) at 4 to 6 L/min or nCPAP/BiPAP at 4 to 6 cmH2O. The study results concluded that the use of HVNI at 4 to 6 L/min was noninferior to nCPAP/BiPAP at 4 to 6 cmH2O with regard to the primary outcome of respiratory support failure, determined by the need for mechanical ventilation within 72 hours from the beginning of the study mode. Failure of the noninvasive respiratory support within 72 hours from the beginning of the study occurred in 17 of the 158 infants in the HVNI group (10.8%) and 15 of the 158 infants in the nCPAP/BiPAP group (9.5%) (95% CI of risk difference, −6.0% to 8.6%; P = .71). The use of HVNI was also noninferior to nCPAP/BiPAP when applying a per-protocol analysis. There were no significant differences in failure rates between the 2 modes in any of the Gestational Age (GA) strata.
Additionally, there was no difference between the groups in any of the respiratory and extra respiratory secondary outcomes explored. The HVNI and nCPAP/BiPAP groups were similar in overall duration of respiratory support (median, 4.0 vs 4.0 days; p = .45),days of noninvasive respiratory support(median, 3.5 vs 3.5 days; p = .48), days of oxygen supplementation (median 0.0 vs 0.0 ; p = .43), need for surfactant (44.3% vs 46.2%; p = .73), and duration of caffeine treatment (median, 12.0 vs 15.0 days; p = .25). The rate of air leaks was similarly low for both modes (1.9% vs 2.5%; p = .70). Finally, the researchers did not find a significant between-group difference in the rate of bronchopulmonary dysplasia (BPD) (4.4% vs 5.1%; p = .79). In addition, the combined outcome of “any adverse event” was not significantly different between the 2 groups.
The study by Lavizarri et al. was the first large RCT comparing HVNI with nCPAP/BiPAP in preterm infants exclusively as primary therapy for RDS. The study demonstrated that the use of HVNI was noninferior to nCPAP/BiPAP with regard to the primary outcome of the need for mechanical ventilation within 72 hours from the beginning of respiratory support. The authors found that HVNI has efficacy and safety similar to those of nCPAP/BiPAP when applied exclusively as primary treatment to mild to moderate RDS in preterm infants older than 28 weeks’ GA and note that the findings of this study can be translated to the acute phase of RDS, when lung de-recruitment and the trend to alveolar collapse still play an important role in the pathogenesis of respiratory failure.
According to the study results, the pressure generated in HVNI up to 6 L/min seems to be safe and to not affect the efficacy of the respiratory support compared with nCPAP/BiPAP at the settings applied in the study. Additionally, no differences were found in terms of incidence of prematurity-associated complications or their combined outcome, suggesting comparable safety between the study modes for these age groups.
The results demonstrated that HVNI provides support for respiratory distress in preterm infants older than 28 weeks’ GA. The use of HVNI showed efficacy and safety similar to those of standard nCPAP or BiPAP when applied exclusively as the primary approach to mild to moderate RDS in preterm infants between 29+0 and 36+6 weeks’ GA. The authors note that randomized clinical trials should be conducted to verify the findings concerning the use of HVNI in preterm infants with RDS in a wider context. In addition, further studies are needed to investigate the role of HVNI in managing RDS in infants with younger GA and lower weight. Because a consensus on how to administer HVNI is missing, future research should address how to optimize this technique in preterm infants in diverse pathophysiological contexts.
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