Respiratory distress syndrome (RDS) is common in very preterm infants due to surfactant deficiency. Surfactant replacement therapy is lifesaving, and current guidelines recommend the less invasive surfactant administration (LISA) technique. However, the optimal duration of surfactant instillation during LISA has never been systematically evaluated. Rapid instillation may provoke transient hypoxia and bradycardia, while slower administration might improve physiological stability and cerebral oxygenation.
This randomised controlled trial investigates whether the duration of surfactant administration (1 minute versus 5 minutes) affects cerebral and systemic oxygen stability in extremely preterm neonates (\< 28 weeks).
Preterm neonate <28+0 weeks (gestational age up to 27 weeks and 6 days)
Indication of surfactant administration via the LISA method
Postnatal age < 72 hours
Invasive ventilation, indication of INSURE procedure
Severe pulmonary or cardiac malformation affecting oxygenation or congenital cerebral malformation
Preexisiting diagnose of any IVH > grade 2 or PVH.
Parallel
Poractant alfa (Curosurf®) - 1-minute administration
DrugPoractant alfa (Curosurf®, Chiesi Pharmaceuticals) administered intratracheally via the Less Invasive Surfactant Administration (LISA) technique over 1 minute. The surfactant is instilled manually through a thin catheter under direct laryngoscopy while the infant remains on continuous positive airway pressure (CPAP) and spontaneous breathing. Pre-specified criteria for aborting the LISA procedure are prolonged bradycardia (HR \< 80 bpm) and/or arterial hypoxia (SpO2 \< 80%) over 60 seconds during surfactant administration starting after the instillation of the LISA catheter. Data of included participants with discontinuation will be collected and analysed.
Poractant alfa (Curosurf®) - 5-minute administration
DrugPoractant alfa (Curosurf®, Chiesi Pharmaceuticals) administered intratracheally via the Less Invasive Surfactant Administration (LISA) technique over 5 minute. The surfactant is instilled manually through a thin catheter under direct laryngoscopy while the infant remains on continuous positive airway pressure (CPAP) and spontaneous breathing. Pre-specified criteria for aborting the LISA procedure are prolonged bradycardia (HR \< 80 bpm) and/or arterial hypoxia (SpO2 \< 80%) over 60 seconds during surfactant administration starting after the instillation of the LISA catheter. Data of included participants with discontinuation will be collected and analysed.
Change in cerebral oxygenation (crSO₂) during and after LISA
The primary outcome measure will be the maximum change of crSO2 from baseline till the end of the primary window (=duration of LISA administration + 15 minutes after removal of the thin catheter). Mean values of crSO2 during the 5min before intervention started is defined as the baseline. crSO2 parameters with beginning five minute before surfactant administration till 15 minutes after extubating will be assessed every minute.
Change in arterial oxygen saturation (SpO₂) during and after LISA
The secondary outcome measure will be the maximum change of SpO2 from baseline till the end of the primary window (=duration of LISA administration + 15 minutes after removal of the thin catheter). Mean values of SpO2 during the 5min before intervention started is defined as the baseline. SpO2 parameters with beginning five minute before surfactant administration till 15 minutes after extubating will be assessed every minute.
Change in heart rate (HR) during and after LISA
The secondary outcome measure will be the maximum change of HR from baseline till the end of the primary window (=duration of LISA administration + 15 minutes after removal of the thin catheter). Mean values of HR during the 5min before intervention started is defined as the baseline. HR parameters with beginning five minute before surfactant administration till 15 minutes after extubating will be assessed every minute.
Change in crSO2 up to three hours after LISA
The secondary outcome measures will be crSO2 up to three hours after surfactant administration defined as maximum changes/drop from starting with the beginning of the surfactant administration after insertion of the thin catheter till three hours after LISA procedure. Vital parameters will be assessed every five minutes till three hours after LISA procedure.
Change in SpO2 up to three hours after LISA
The secondary outcome measures will be SpO2 up to three hours after surfactant administration defined as maximum changes/drop from starting with the beginning of the surfactant administration after insertion of the thin catheter till three hours after LISA procedure. Vital parameters will be assessed every five minutes till three hours after LISA procedure.
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