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

RecruitingPhase 4Ages 0 Months - 72 HoursAllMedical University of Graz
NCT07261787 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
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.
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What it tests

  • Poractant alfa (Curosurf®) - 1-minute administration
  • Poractant alfa (Curosurf®) - 5-minute administration
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Where

1 site
Medical University of Graz, Division of Neonatology, Department of Pediatrics and Adolescent Medicine
Graz, Austria
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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