Nasal High-Flow Therapy for Newborn Infants in Special Care Nurseries
| Autor: | Brett J, Manley, Gaston R B, Arnolda, Ian M R, Wright, Louise S, Owen, Jann P, Foster, Li, Huang, Calum T, Roberts, Tracey L, Clark, Wei-Qi, Fan, Alice Y W, Fang, Isaac R, Marshall, Rosalynn J, Pszczola, Peter G, Davis, Adam G, Buckmaster, Susan, Donath |
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| Rok vydání: | 2019 |
| Předmět: |
Male
Pediatrics medicine.medical_specialty medicine.medical_treatment 030204 cardiovascular system & hematology law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law Intensive Care Units Neonatal Positive airway pressure otorhinolaryngologic diseases Humans Medicine Treatment Failure 030212 general & internal medicine Continuous positive airway pressure Respiratory system Respiratory Distress Syndrome Newborn Noninvasive Ventilation Lung Continuous Positive Airway Pressure business.industry Infant Newborn Oxygen Inhalation Therapy General Medicine respiratory system Cannula respiratory tract diseases Clinical research medicine.anatomical_structure Female Special care business |
| Zdroj: | New England Journal of Medicine. 380:2031-2040 |
| ISSN: | 1533-4406 0028-4793 |
| DOI: | 10.1056/nejmoa1812077 |
| Popis: | Nasal high-flow therapy is an alternative to nasal continuous positive airway pressure (CPAP) as a means of respiratory support for newborn infants. The efficacy of high-flow therapy in nontertiary special care nurseries is unknown.We performed a multicenter, randomized, noninferiority trial involving newborn infants (24 hours of age; gestational age, ≥31 weeks) in special care nurseries in Australia. Newborn infants with respiratory distress and a birth weight of at least 1200 g were assigned to treatment with either high-flow therapy or CPAP. The primary outcome was treatment failure within 72 hours after randomization. Infants in whom high-flow therapy failed could receive CPAP. Noninferiority was determined by calculating the absolute difference in the risk of the primary outcome, with a noninferiority margin of 10 percentage points.A total of 754 infants (mean gestational age, 36.9 weeks, and mean birth weight, 2909 g) were included in the primary intention-to-treat analysis. Treatment failure occurred in 78 of 381 infants (20.5%) in the high-flow group and in 38 of 373 infants (10.2%) in the CPAP group (risk difference, 10.3 percentage points; 95% confidence interval [CI], 5.2 to 15.4). In a secondary per-protocol analysis, treatment failure occurred in 49 of 339 infants (14.5%) in the high-flow group and in 27 of 338 infants (8.0%) in the CPAP group (risk difference, 6.5 percentage points; 95% CI, 1.7 to 11.2). The incidences of mechanical ventilation, transfer to a tertiary neonatal intensive care unit, and adverse events did not differ significantly between the groups.Nasal high-flow therapy was not shown to be noninferior to CPAP and resulted in a significantly higher incidence of treatment failure than CPAP when used in nontertiary special care nurseries as early respiratory support for newborn infants with respiratory distress. (Funded by the Australian National Health and Medical Research Council and Monash University; HUNTER Australian and New Zealand Clinical Trials Registry number, ACTRN12614001203640.). |
| Databáze: | OpenAIRE |
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