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Study comparing prophylactic versus selective surfactant (poractant alfa, phospholipid fraction) administration in preterm infants with respiratory distress syndrome aged 25-30 weeks

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on studying Respiratory Distress Syndrome in preterm infants. The study compares two different approaches to administering surfactant medications - Alveofact and Curosurf - which are substances that help babies breathe more easily by keeping their lung air sacs open. The purpose is to determine if giving surfactant preventively works better than giving it only when needed, using a technique called Less Invasive Surfactant Administration.

The medications used in this study contain natural substances similar to those normally found in the lungs. Poractant alfa (Curosurf) and phospholipid fraction (Alveofact) are given directly into the breathing tubes of the lungs. These treatments are specifically designed for premature babies whose lungs are not fully developed at birth.

The study will follow the development of premature babies from birth until they reach 5 years of age. During this time, doctors will monitor how well the children can breathe and how their lungs develop. The main focus will be on measuring how well these children can exhale air from their lungs when they reach the age of 5 years.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Your eligibility will be evaluated within the first 60 minutes after birth if you are a preterm infant born between 25 weeks and 30 weeks plus 6 days of pregnancy

    Your breathing will be supported using CPAP (Continuous Positive Airway Pressure) device

    Your oxygen saturation levels must be at least 90% while receiving 30% or less oxygen in the breathing air

  2. Step 2

    Treatment administration

    You will receive one of two medications through your breathing tube:

    Either ALVEOFACT (45 mg/ml) or Curosurf (120 mg suspension)

    The medication will be given directly into your lungs through a special technique called Less Invasive Surfactant Administration

  3. Step 3

    Monitoring period

    Your breathing and overall health will be monitored throughout your hospital stay

    Regular assessments will be conducted to track your progress

  4. Step 4

    Long-term follow-up at age 5

    Your lung function will be tested, measuring how much air you can breathe out in one second

    Additional tests will include:

    - Measurement of your total lung capacity

    - A three-minute walking test

    - Assessment of your movement abilities

    - Evaluation of your development and thinking skills

Who can join the trial?

6 criteria

  • Patient must be a premature baby born between 25 weeks and 30 weeks plus 6 days of pregnancy
  • Baby must be less than 60 minutes old at the time of enrollment
  • Baby must be able to breathe on their own while using CPAP (Continuous Positive Airway Pressure - a device that helps keep airways open)
  • Baby's oxygen levels must be at least 90% when measured by pulse oximeter (a device that measures oxygen in blood through the skin), while receiving no more than 30% oxygen in breathing support
  • Parents or legal guardians must provide written consent for the baby to participate in the study (this can be obtained after enrollment if necessary)
  • Both male and female babies can participate

Who cannot join the trial?

9 criteria

  • Infants born before 25 weeks or after 30 weeks and 6 days of pregnancy
  • Infants with major congenital abnormalities (birth defects that significantly affect body structure or function)
  • Infants who have already received surfactant treatment (a substance that helps keep the lungs inflated)
  • Infants with severe respiratory failure requiring immediate mechanical ventilation
  • Infants whose parents or legal guardians have not provided informed consent
  • Infants with known genetic disorders that could affect lung development
  • Infants participating in other clinical trials that could interfere with this study
  • Infants whose families plan to move away from the study area before the child reaches 5 years of age
  • Infants with conditions that would prevent them from completing lung function tests at age 5
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Investigated drugs

Surfactant is a natural substance that helps keep the tiny air sacs in the lungs open, making it easier to breathe. In this trial, it's given to premature babies to help their underdeveloped lungs work better. The medication is administered directly into the lungs through a thin tube, using a technique called "Less Invasive Surfactant Administration" (LISA). This treatment helps prevent breathing difficulties in premature infants and supports their lung development.

What is already known about the treatment

Surfactant - A naturally occurring substance administered directly into the lungs of premature infants through less invasive surfactant administration (LISA) technique to treat or prevent respiratory distress syndrome. This medication is a mixture of proteins and phospholipids that helps reduce surface tension in the lungs' air sacs, making breathing easier for premature babies whose lungs haven't yet developed enough natural surfactant. The treatment is widely recognized in neonatal medicine as a crucial intervention for preterm infants between 25 and 30 weeks of gestational age, significantly improving their lung function and respiratory outcomes. The medication works at the molecular level by spreading across the surface of lung alveoli, preventing them from collapsing during exhalation and reducing the work required for breathing.

Investigated diseases

Respiratory Distress Syndrome - A breathing disorder that primarily affects premature infants whose lungs haven't fully developed. The condition occurs when the lungs lack a protective substance called surfactant, which helps the tiny air sacs in the lungs stay open. Without enough surfactant, the lungs cannot expand properly, making it difficult for the baby to breathe. The condition typically develops within the first few hours after birth. Breathing becomes rapid and labored, with visible signs like grunting, flaring nostrils, and chest retractions. The severity of RDS usually depends on how premature the infant is and how underdeveloped their lungs are at birth.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2024-516504-42-00Protocol codepro.LISA_01_21Estimated enrolment578 patientsSponsorUniversitaetsklinikum Schleswig-Holstein AöR

sourced from the EU Clinical Trials Register and site verification

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