Archives of disease in childhood. Fetal and neonatal edition · 2018
Nebulised surfactant to reduce severity of respiratory distress: a blinded, parallel, randomised controlled trial.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Minocchieri Stefan, Berry Clare A, Pillow J Jane, CureNeb Study Team
Аннотация
OBJECTIVE: To evaluate if nebulised surfactant reduces intubation requirement in preterm infants with respiratory distress treated with nasal continuous positive airway pressure (nCPAP).
DESIGN: Double blind, parallel, stratified, randomised control trial.
SETTING: Sole tertiary neonatal unit in West Australia.
PATIENTS: Preterm infants (290-336 weeks' gestational age, GA) less than 4 hours of age requiring 22%-30% supplemental oxygen, with informed parental written consent.
INTERVENTIONS: Infants were randomised within strata (290-316 and 320-336 weeks' GA) to bubble nCPAP or bubble nCPAP and nebulised surfactant (200 mg/kg: poractant alfa) using a customised vibrating membrane nebuliser (eFlow neonatal). Surfactant nebulisation (100 mg/kg) was repeated after 12 hours for persistent supplemental oxygen requirement.
MAIN OUTCOME MEASURES: The primary outcomes were requirement for intubation and duration of mechanical ventilation at 72 hours. Data analysis followed the intention-to-treat principle.
RESULTS: 360 of 606 assessed infants were eligible; 64 of 360 infants were enrolled and randomised (n=32/group). Surfactant nebulisation reduced the requirement for intubation within 72 hours: 11 of 32 infants were intubated after continuous positive airway pressure (CPAP) and nebulised surfactant compared with 22 of 32 infants receiving CPAP alone (relative risk (95% CI)=0.526 (0.292 to 0.950)). The reduced requirement for intubation was limited to the 320-336 weeks' GA stratum. The median (range) duration of ventilation in the first 72 hours was not different between the intervention (0 (0-62) hours) and control (9 (0-64) hours; p=0.220) groups. There were no major adverse events.
CONCLUSIONS: Early postnatal nebulised surfactant may reduce the need for intubation in the first 3 days of life compared with nCPAP alone in infants born at 290-336 weeks' GA with mild respiratory distress syndrome. Confirmation requires further adequately powered studies.
TRIAL REGISTRATION NUMBER: ACTRN12610000857000.
DESIGN: Double blind, parallel, stratified, randomised control trial.
SETTING: Sole tertiary neonatal unit in West Australia.
PATIENTS: Preterm infants (290-336 weeks' gestational age, GA) less than 4 hours of age requiring 22%-30% supplemental oxygen, with informed parental written consent.
INTERVENTIONS: Infants were randomised within strata (290-316 and 320-336 weeks' GA) to bubble nCPAP or bubble nCPAP and nebulised surfactant (200 mg/kg: poractant alfa) using a customised vibrating membrane nebuliser (eFlow neonatal). Surfactant nebulisation (100 mg/kg) was repeated after 12 hours for persistent supplemental oxygen requirement.
MAIN OUTCOME MEASURES: The primary outcomes were requirement for intubation and duration of mechanical ventilation at 72 hours. Data analysis followed the intention-to-treat principle.
RESULTS: 360 of 606 assessed infants were eligible; 64 of 360 infants were enrolled and randomised (n=32/group). Surfactant nebulisation reduced the requirement for intubation within 72 hours: 11 of 32 infants were intubated after continuous positive airway pressure (CPAP) and nebulised surfactant compared with 22 of 32 infants receiving CPAP alone (relative risk (95% CI)=0.526 (0.292 to 0.950)). The reduced requirement for intubation was limited to the 320-336 weeks' GA stratum. The median (range) duration of ventilation in the first 72 hours was not different between the intervention (0 (0-62) hours) and control (9 (0-64) hours; p=0.220) groups. There were no major adverse events.
CONCLUSIONS: Early postnatal nebulised surfactant may reduce the need for intubation in the first 3 days of life compared with nCPAP alone in infants born at 290-336 weeks' GA with mild respiratory distress syndrome. Confirmation requires further adequately powered studies.
TRIAL REGISTRATION NUMBER: ACTRN12610000857000.