Not Yet RecruitingPhase 4

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

Austria76 participantsStarted 2025-12-01

Plain-language 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).

Who can participate

Age range0 Months – 72 Hours

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change in cerebral oxygenation (crSO₂) during and after LISA

Timeframe: From baseline (= 5min before insertion of the LISA catheter) till 15 minutes after removal of the thin catheter

Trial details

NCT IDNCT07261787

SponsorMedical University of Graz

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-07-01

Contact for this trial

Christina H. Wolfsberger, Priv.Doz. DDr.

+43 316 385 81135 christina.wolfsberger@medunigraz.at