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Duration of Surfactant administration and impact on Stabilisation of vital parameters in very preterm neonates: 1 minute versus 5 minutes – a prospective randomised-controlled phase IV trial

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-522754-39-00
Enrollment
76
Registered
2025-12-01
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal respiratory distress syndrome

Brief summary

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.

Detailed description

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., Need of supplemental oxygen, the amount of bradycardia and hypoxia (in minutes); up to three hours after surfactant administration., Vital parameters until three hours after extubation, assessed every five minutes., Need for a second/repetitive dose of surfactant, Invasive ventilation during the first two days after initial surfactant administration., short-term outcome (morbidity) until discharge or term age dependent on what comes first.

Interventions

DRUGCurosurf® 240 mg Suspension zur endotracheopulmonalen Instillation

Sponsors

Medical University Of Graz
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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., Need of supplemental oxygen, the amount of bradycardia and hypoxia (in minutes); up to three hours after surfactant administration., Vital parameters until three hours after extubation, assessed every five minutes., Need for a second/repetitive dose of surfactant, Invasive ventilation during the first two days after initial surfactant administration., short-term outcome (morbidity) until discharge or term age dependent on what comes first.

Countries

Austria

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026