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A randomised controlled trial in preterm infants comparing prophylactic with selective “Less Invasive Surfactant Administration” (pro.LISA)
EU CTIS ID: 2024-516504-42-00
What this study is testing
The aim of the pro.LISA study is to clarify the question of whether prophylactic use of surfactant in premature infants with a gestational age of 25 weeks + 0 days to 30 weeks + 6 days leads to an improved forced expiratory volume within the first second (FEV1) at the age of 5 years. The aim of the pro.LISA study is to clarify the question of whether prophylactic use of surfactant in preterm infants with a gestational age of 25 weeks + 0 days to 30 weeks + 6 days leads to an improved forced expiratory volume within the first second (FEV1) at the age of 5 years.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Preterm infants with a gestational age of 25+0 to 30+6 weeks of pregnancy
- Age <= 60 minutes
- Spontaneous breathing on CPAP
- Pulse oximetrically measured saturation >=90% with a FiO2 <= 30%
- Written informed consent of the legal guardian(s) (retrospectively if necessary)
You likely can't join if
- Malformations or diseases with a probable lethal outcome
- Hypersensitivity to surfactant, sodium hydrogen carbonate or sodium chloride
The study team makes the final eligibility decision.
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, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.