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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 - A Randomised Clinical Trial on Influence of Duration of Surfactant Administration on Stabilisation of Routine Monitoring Parameters and Cerebral Tissue Oxygen Saturation Monitoring in Preterm Neonates < 28 Weeks of Gestational Age

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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).

Eligibility
Participation Requirements
Sex: All
Maximum Age: 3 days
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Austria
Medical University of Graz, Division of Neonatology, Department of Pediatrics and Adolescent Medicine
RECRUITING
Graz
Contact Information
Primary
Christina H. Wolfsberger, Priv.Doz. DDr.
christina.wolfsberger@medunigraz.at
+43 316 385 81135
Backup
Gerhard Pichler, Univ.Prof. PD. Dr.
gerhard.pichler@medunigraz.at
+43 316 385 80520
Time Frame
Start Date: 2026-02-20
Estimated Completion Date: 2028-12-01
Participants
Target number of participants: 76
Treatments
Experimental: 1-Minute Administration (1-min-group)
Infants receive poractant alfa (Curosurf®) administered via the LISA technique over 1 minute.
Experimental: 5-Minute Administration (5-min-group)
Infants receive poractant alfa (Curosurf®) administered via the LISA technique over 5 minutes.
Sponsors
Leads: Medical University of Graz

This content was sourced from clinicaltrials.gov