drugset / Trial / NCT07261787

Duration of Surfactant Administration and Impact on Stabilisation of Vital Parameters in Very Preterm Neonates: 1 Minutes Versus 5 Minutes

NCT07261787

Phase 4 Recruiting 76 enrolled Medical University of Graz
RandomizedParallel-groupOpen-labelTreatment

Summary

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).

Timeline

Start
2026-02-20
Primary completion
2028-07-01
Completion
2028-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Poractant alfa Other / unclassified Other