NCT07261787 Duration of Surfactant Administration and Impact on Stabilisation of Vital Parameters in Very Preterm Neonates: 1 Minutes Versus 5 Minutes
| NCT ID | NCT07261787 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Medical University of Graz |
| Condition | Neonates and Preterm Infants |
| Study Type | INTERVENTIONAL |
| Enrollment | 76 participants |
| Start Date | 2026-02-20 |
| Primary Completion | 2028-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 76 participants in total. It began in 2026-02-20 with a primary completion date of 2028-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07261787 clinical trial?
This trial is open to participants of all sexes, aged 0 Months or older, up to 72 Hours, studying Neonates and Preterm Infants. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07261787 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07261787 currently recruiting?
Yes, NCT07261787 is actively recruiting participants. Contact the research team at christina.wolfsberger@medunigraz.at for enrollment information.
Where is the NCT07261787 trial being conducted?
This trial is being conducted at Graz, Austria.
Who is sponsoring the NCT07261787 clinical trial?
NCT07261787 is sponsored by Medical University of Graz. The trial plans to enroll 76 participants.