Actively Recruiting
Duration of Surfactant Administration and Impact on Stabilisation of Vital Parameters in Very Preterm Neonates: 1 Minute Versus 5 Minutes - a Prospective Randomised-controlled Phase IV Trial
Led by Medical University of Graz · Updated on 2026-05-14
76
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Respiratory distress syndrome (RDS) frequently affects very preterm infants due to a lack of surfactant. This research evaluates whether the speed of surfactant administration using the less invasive surfactant administration (LISA) technique influences oxygen stability in extremely preterm babies born before 28 weeks of gestation. The trial compares giving surfactant over 1 minute versus 5 minutes to understand effects on brain and body oxygen levels. In this single-center, phase IV trial, infants needing surfactant are randomly assigned to receive poractant alfa either rapidly over 1 minute or more slowly over 5 minutes via the LISA method. The surfactant is delivered through a thin catheter while the infant breathes spontaneously with continuous positive airway pressure. The study examines two commonly used administration durations within current guidelines. Participants are continuously monitored for cerebral oxygen levels using near-infrared spectroscopy from 5 minutes before until 3 hours after surfactant delivery. Researchers also track heart rate, blood oxygen, blood pressure, and episodes of low oxygen or slow heart rate. The study aims to measure changes in cerebral oxygen saturation within 15 minutes after the procedure and observe the need for further surfactant or ventilation over 48 hours. Outcomes like lung disease and brain bleeding are assessed up to corrected ages of 36 to 40 weeks. The study plans to enroll 76 infants in total.
CONDITIONS
Brief Title
Duration of Surfactant Administration and Impact on Stabilisation of Vital Parameters in Very Preterm Neonates: 1 Minutes Versus 5 Minutes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Preterm neonate less than 28 weeks gestational age (up to 27 weeks and 6 days)
- Requires surfactant administration using the less invasive surfactant administration (LISA) method
- Postnatal age less than 72 hours
You will not qualify if you...
- Currently receiving invasive ventilation or indication for INSURE procedure
- Severe lung or heart malformations affecting oxygenation
- Congenital cerebral malformations
- Existing diagnosis of intraventricular hemorrhage greater than grade 2 or periventricular hemorrhagic infarction
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 72 hours after birth
Participants are screened for eligibility to participate in the trial.
Duration - Single administration within 72 hours after birth
Participants receive poractant alfa administered via the Less Invasive Surfactant Administration (LISA) technique over either 1 minute or 5 minutes to stabilize vital parameters.
1 administration visit (in-person) with continuous monitoring from 5 minutes before to 3 hours after the procedure
Trial Site Locations
Total: 1 location
1
Medical University of Graz, Division of Neonatology, Department of Pediatrics and Adolescent Medicine
Graz, Austria, 8036
Actively Recruiting
Research Team
C
Christina H. Wolfsberger, Priv.Doz. DDr.
G
Gerhard Pichler, Univ.Prof. PD. Dr.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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