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Original Investigation | Journal Club

Heated, Humidified High-Flow Nasal Cannula vs Nasal Continuous Positive Airway Pressure for Respiratory Distress Syndrome of Prematurity A Randomized Clinical Noninferiority Trial ONLINE FIRST

Anna Lavizzari, MD1; Mariarosa Colnaghi, MD1; Francesca Ciuffini, MD1; Chiara Veneroni, PhD2; Stefano Musumeci1; Ivan Cortinovis3; Fabio Mosca, MD1
[+] Author Affiliations
1Neonatal Intensive Care Unit, Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico, Department of Clinical Sciences and Community Health, Università degli Studi di Milano, Milan, Italy
2TBM Laboratory, Department of Electronics, Information, and Bioengineering, Politecnico di Milano University, Milan, Italy
3Laboratory GA Maccaro, Department of Clinical Sciences and Community Health, Università degli Studi di Milano, Milan, Italy
JAMA Pediatr. Published online August 08, 2016. doi:10.1001/jamapediatrics.2016.1243
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Importance  Heated, humidified high-flow nasal cannula (HHHFNC) has gained increasing popularity as respiratory support for newborn infants thanks to ease of use and improved patient comfort. However, its role as primary therapy for respiratory distress syndrome (RDS) of prematurity needs to be further elucidated by large, randomized clinical trials.

Objective  To determine whether HHHFNC provides respiratory support noninferior to nasal continuous positive airway pressure (nCPAP) or bilevel nCPAP (BiPAP) as a primary approach to RDS in infants older than 28 weeks’ gestational age (GA).

Design, Setting, and Participants  An unblinded, monocentric, randomized clinical noninferiority trial at a tertiary neonatal intensive care unit. Inborn infants at 29 weeks 0 days to 36 weeks 6 days of GA were eligible if presenting with mild to moderate RDS requiring noninvasive respiratory support. Criteria for starting noninvasive respiratory support were a Silverman score of 5 or higher or a fraction of inspired oxygen higher than 0.3 for a target saturation of peripheral oxygen of 88% to 93%. Infants were ineligible if they had major congenital anomalies or severe RDS requiring early intubation. Infants were enrolled between January 5, 2012, and June 28, 2014.

Interventions  Randomization to either HHHFNC at 4 to 6 L/min or nCPAP/BiPAP at 4 to 6 cm H2O.

Main Outcomes and Measures  Need for mechanical ventilation within 72 hours from the beginning of respiratory support. The absolute risk difference in the primary outcome and its 95% confidence interval were calculated to determine noninferiority (noninferiority margin, 10%). An intention-to-treat analysis was performed.

Results  A total of 316 infants were enrolled in the study: 158 in the HHHFNC group (mean [SD] GA, 33.1 [1.9] weeks; 52.5% female) and 158 in the nCPAP/BiPAP group (mean [SD] GA, 33.0 [2.1] weeks; 47.5% female). The use of HHHFNC was noninferior to nCPAP with regard to the primary outcome: failure occurred in 10.8% vs 9.5% of infants, respectively (95% CI of risk difference, −6.0% to 8.6% [within the noninferiority margin]; P = .71). Significant between-group differences in secondary outcomes were not found between the HHHFNC and nCPAP/BiPAP groups, including duration of respiratory support (median [interquartile range], 4.0 [2.0 to 6.0] vs 4.0 [2.0 to 7.0] days; 95% CI of difference in medians, −1.0 to 0.5; P = .45), need for surfactant (44.3% vs 46.2%; 95% CI of risk difference, −9.8 to 13.5; P = .73), air leaks (1.9% vs 2.5%; 95% CI of risk difference, −3.3 to 4.5; P = .70), and bronchopulmonary dysplasia (4.4% vs 5.1%; 95% CI of risk difference, −3.9 to 7.2; P = .79).

Conclusions and Relevance  In this study, HHHFNC showed efficacy and safety similar to those of nCPAP/BiPAP when applied as a primary approach to mild to moderate RDS in preterm infants older than 28 weeks’ GA.

Trial Registration  clinicaltrials.gov Identifier: NCT02570217

Figures in this Article

Figures

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Figure 1.
The CONSORT Flow Diagram

HHHFNC indicates heated, humidified high-flow nasal cannula; nCPAP, nasal continuous positive airway pressure.

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Figure 2.
Possible Scenarios of Results for a Noninferiority Trial and Results of This Study

A, Possible scenarios of results for a noninferiority trial according to Piaggio et al.29 B, Results of this study concerning the primary outcome according to both intention-to-treat analysis and per-protocol analysis. BiPAP indicates bilevel nasal continuous positive airway pressure; nCPAP, nasal continuous positive airway pressure; NIM, noninferiority margin; and error bars, 95% confidence interval of the risk difference.

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