Duration of surfactant administration: 1 minute vs 5 minutes in very preterm babies
Official title: 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
Run by Medical University of Graz · NCT07261787 · Data updated 2026-11-12
This trial tests whether giving surfactant over 1 minute or 5 minutes during the LISA procedure helps stabilize cerebral and overall oxygen levels in extremely preterm infants.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 0 Months to 72 Hours |
| Sex | All |
| Enrollment | 76 (estimated) |
| Sponsor | Medical University of Graz Academic / other |
| Locations | 1 site (Graz) |
| Status | Recruiting |
| Started | February 20, 2026 |
| Main results expected | July 1, 2028 |
| Study ends | December 1, 2028 |
| Registry record updated | May 14, 2026 |
| Trial ID | NCT07261787 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Preterm neonates <28 weeks gestational age requiring surfactant via the LISA technique within 72 hours of birth.
✕Probably not a fit
Infants with invasive ventilation, significant congenital heart or lung malformations, higher-grade IVH/PVH, or those outside the inclusion window may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The SurfStab I Trial is a single-center, randomized, phase IV study at the Medical University of Graz that compares two durations of poractant alfa administration during LISA in infants born before 28 weeks. Participants are randomly assigned to receive surfactant over 1 minute or 5 minutes, with continuous cerebral oxygenation monitored by NIRS from before the procedure to three hours after. Primary outcome is the maximal change in cerebral oxygen saturation from baseline to 15 minutes post-procedure; secondary outcomes include peripheral oxygen saturation, heart rate, mean arterial pressure, hypoxic or bradycardic episodes, and need for additional surfactant or invasive ventilation. The trial aims to determine if slower administration improves physiological stability and cerebral oxygenation, potentially guiding future practice for extremely preterm newborn care.
Why it matters
Potential benefit: If slower administration proves safer, it could improve cerebral oxygenation and stability during surfactant delivery.
How similar studies have gone: Previous evidence on administration duration is limited; this trial addresses a previously unanswered question in a rigorous randomized design.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Invasive ventilation, indication of INSURE procedure * Severe pulmonary or cardiac malformation affecting oxygenation or congenital cerebral malformation * Preexisiting diagnose of any IVH \> grade 2 or PVH.
Where it's running
-
Medical University of Graz, Division of Neonatology, Department of Pediatrics and Adolescent Medicine
Graz, Austria Recruiting
Study contacts
- Study coordinator: Christina H. Wolfsberger, Priv.Doz. DDr.
- Email: christina.wolfsberger@medunigraz.at
- Phone: +43 316 385 81135
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.