Clinical Trial

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

Study acronym: SurfStab I
Recruiting Phase 4
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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).
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-11-28.
Status change: Not Yet Recruiting → Recruiting 2026-05-12
Trial Details
NCT Number NCT07261787
Lead Sponsor Medical University of Graz
Conditions Neonates and Preterm Infants, Infant Respiratory Distress Syndrome, Surfactant Deficiency Syndrome Neonatal, Surfactant, Cerebral Oxygenation, Cerebral Oxygen Saturation
Enrollment 76 participants
Start Date 2026-02-20
Primary Completion 2028-07-01 (estimated)
Study Completion 2028-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-14