Nebulised surfactant to reduce severity of respiratory distress: A blinded, parallel, randomised controlled trial

Stefan Minocchieri, Clare A. Berry, J. Jane Pillow

Research output: Contribution to journalArticle

12 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)F313-F319
Number of pages7
JournalArchives of Disease in Childhood: Fetal and Neonatal Edition
Volume104
Issue number3
DOIs
Publication statusPublished - May 2019

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Continuous Positive Airway Pressure
Surface-Active Agents
Intubation
Randomized Controlled Trials
Gestational Age
Premature Infants
Parental Consent
Oxygen
Nebulizers and Vaporizers
Artificial Respiration
Ventilation
Outcome Assessment (Health Care)
Membranes

Cite this

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title = "Nebulised surfactant to reduce severity of respiratory distress: A blinded, parallel, randomised controlled trial",
abstract = "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.",
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Nebulised surfactant to reduce severity of respiratory distress : A blinded, parallel, randomised controlled trial. / Minocchieri, Stefan; Berry, Clare A.; Pillow, J. Jane.

In: Archives of Disease in Childhood: Fetal and Neonatal Edition, Vol. 104, No. 3, 05.2019, p. F313-F319.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Nebulised surfactant to reduce severity of respiratory distress

T2 - A blinded, parallel, randomised controlled trial

AU - Minocchieri, Stefan

AU - Berry, Clare A.

AU - Pillow, J. Jane

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N2 - 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.

AB - 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.

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KW - nebulization

KW - respiratory distress syndrome

KW - surfactant

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