PORACTANT ALFA for Neonatal respiratory distress syndrome

Inclusion criteria

• {"criterion_text":"- Preterm neonate <28+0 weeks (gestational age up to 27 weeks and 6 days)"}
• {"criterion_text":"- Indication of surfactant administration via the LISA method"}
• {"criterion_text":"- Postnatal age < 72 hours"}

Exclusion criteria

• {"criterion_text":"- Invasive ventilation, indication of INSURE procedure"}
• {"criterion_text":"- Severe pulmonary or cardial malformation affecting oxygenation or congenital cerebral malformation"}
• {"criterion_text":"- Preexisiting diagnose of any IVH > grade 2 or PVH."}

Primary endpoints

• {"endpoint_text":"- Vital parameters (SpO2, HR and crSO2) during surfactant administration; defined as maximum changes/drop from baseline starting with the beginning of the surfactant administration after insertion of the thin catheter till 15 minutes after the LISA procedure.","definition_or_measurement_approach":"Defined as maximum changes/drop from baseline starting with the beginning of the surfactant administration after insertion of the thin catheter till 15 minutes after the LISA procedure."}

Secondary endpoints

• {"endpoint_text":"- SpO2, HR, crSO2 and MABP up to three hours after surfactant administration; defined as maximum changes/drop from baseline starting with the beginning of the surfactant administration after insertion of the thin catheter till three hours after LISA procedure.","definition_or_measurement_approach":"Defined as maximum changes/drop from baseline starting with the beginning of the surfactant administration after insertion of the thin catheter till three hours after LISA procedure."}
• {"endpoint_text":"- Need of supplemental oxygen, the amount of bradycardia and hypoxia (in minutes); up to three hours after surfactant administration.","definition_or_measurement_approach":"Amount (in minutes) of bradycardia and hypoxia and need for supplemental oxygen measured up to three hours after surfactant administration."}
• {"endpoint_text":"- Vital parameters until three hours after extubation, assessed every five minutes.","definition_or_measurement_approach":"Vital parameters assessed every five minutes until three hours after extubation."}
• {"endpoint_text":"- Need for a second/repetitive dose of surfactant","definition_or_measurement_approach":"Recording of requirement for a second/repetitive surfactant dose within specified follow-up."}
• {"endpoint_text":"- Invasive ventilation during the first two days after initial surfactant administration.","definition_or_measurement_approach":"Occurrence of invasive ventilation within first two days after initial surfactant administration."}
• {"endpoint_text":"- short-term outcome (morbidity) until discharge or term age dependent on what comes first.","definition_or_measurement_approach":"Assessment of short-term morbidity outcomes (BPD, IVH, PVH, PVL) until discharge or term age, whichever occurs first."}

Austria

Earliest CTIS Part Ii Submission Date

23-09-2025

Latest Decision Or Authorization Date

01-12-2025

Processing Time Days

69

Number Of Sites

1

Number Of Participants

76

Primary sponsor

Full Name

Medical University Of Graz

Organisation Type

Educational Institution

Country Of Registered Address

Austria