Recruiting PHASE4 Neonates and Preterm Infants

Compares treatment options for Neonates and Preterm Infants

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

ClinicalTrials.gov ID: NCT07261787

What this study is testing

What is Poractant alfa (Curosurf®) - 1-minute administration?

Poractant alfa (Curosurf®) - 1-minute administration is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for neonates and preterm infants.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 4: studies an already-approved treatment
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 0 to 72

You may be able to join if

  • 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

You likely can't join if

  • 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.

The study team makes the final eligibility decision.

Where it's taking place

  • Graz, Austria

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 0 months to 72 hours. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Graz, Austria. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.