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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age0-72
SponsorMedical University of Graz

About this trial

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

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

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

Treatment groups

76 Participants
are divided into 2 treatment groups

Sponsors and collaborators