Heated, Humidified High-Flow Nasal Cannula vs Nasal Continuous Positive Airway Pressure for Respiratory Distress Syndrome of Prematurity : A Randomized Clinical Noninferiority Trial
Articolo
Data di Pubblicazione:
2016
Citazione:
Heated, Humidified High-Flow Nasal Cannula vs Nasal Continuous Positive Airway Pressure for Respiratory Distress Syndrome of Prematurity : A Randomized Clinical Noninferiority Trial / A. Lavizzari, M. Colnaghi, F. Ciuffini, C. Veneroni, S. Musumeci, I. Cortinovis, F. Mosca. - In: JAMA PEDIATRICS. - ISSN 2168-6203. - (2016 Aug 08). [Epub ahead of print] [10.1001/jamapediatrics.2016.1243]
Abstract:
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 cmH2O.
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
Tipologia IRIS:
01 - Articolo su periodico
Elenco autori:
A. Lavizzari, M. Colnaghi, F. Ciuffini, C. Veneroni, S. Musumeci, I. Cortinovis, F. Mosca
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