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Study on Phospholipid Fraction from Porcine Lung for Premature Infants with Respiratory Distress Syndrome (RDS)

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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 a condition known as Respiratory Distress Syndrome (RDS) in premature infants. RDS is a breathing disorder that affects newborns, particularly those born before their lungs have fully developed. The treatment being tested in this study is called Curosurf, which is a type of medication known as an exogenous surfactant. This medication is made from a substance called phospholipid fraction, porcine lung, which helps the lungs function better by reducing surface tension, making it easier for the baby to breathe.

The purpose of the study is to compare two different ways of giving this surfactant to premature babies with RDS. One method uses lung ultrasonography, a technique that uses sound waves to create images of the lungs, to decide when to give the surfactant. The other method follows current medical guidelines. The study aims to see which method is more effective in reducing the need for intubation, a procedure where a tube is placed into the windpipe to help with breathing, during the first 72 hours of life.

Participants in the study will be randomly assigned to one of the two treatment groups. The study is designed to be single-blind, meaning that the healthcare providers know which treatment the baby is receiving, but the parents do not. The trial will monitor the babies closely to see how well they respond to the treatment and to ensure their safety. The goal is to find the best way to help premature infants with RDS breathe more easily and reduce the need for more invasive procedures.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Eligible participants are premature newborns between 24 and 32 weeks and/or weighing 1500 grams or less at birth.
Participants must not meet any exclusion criteria to be included in the study.
Step 2
Initial assessment
Participants undergo an initial assessment using lung ultrasonography to identify early signs of Respiratory Distress Syndrome (RDS).
Step 3
Randomization
Participants are randomly assigned to one of two groups. One group receives treatment based on lung ultrasound criteria, while the other follows current guideline recommendations.
Step 4
Treatment administration
The treatment involves the administration of Curosurf, a suspension containing a phospholipid fraction from porcine lung.
The medication is administered through endotracheopulmonary instillation, which means it is delivered directly into the lungs.
The goal is to reduce the number of intubations required in the first 72 hours of life.
Step 5
Monitoring and follow-up
Participants are monitored for their response to the treatment, focusing on the intubation rate within the first 72 hours.
The study continues until the estimated end date of December 1, 2026.

Who can join the trial?

6 criteria

The study is for **premature newborns**. This means babies born earlier than expected.
The babies should have a condition called **Respiratory Distress Syndrome (RDS)**, which affects their breathing.
Both **boys and girls** can participate in the study.
The babies should be born between **24 and 32 weeks** of pregnancy.
The babies can also weigh **1,500 grams or less** at birth.
The babies must not meet any of the **exclusion criteria**, which are specific reasons that would prevent them from joining the study.

Who cannot join the trial?

5 criteria

Infants who are not born prematurely.
Infants who do not have Respiratory Distress Syndrome (RDS), a condition where the lungs are not fully developed and cause breathing difficulties.
Infants who have other serious health conditions that could interfere with the study.
Infants who have already received treatment that could affect the study results.
Infants whose parents or guardians do not consent to participate in the study.

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Hospital De La Santa Creu I Sant Pau
Barcelona, Spain

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Investigated drugs

Exogenous Pulmonary Surfactant is a medication used to treat premature infants with Respiratory Distress Syndrome (RDS). It helps the lungs function better by reducing the surface tension in the lungs, making it easier for the baby to breathe. In this clinical trial, the surfactant is administered to preterm newborns to see if different methods of giving the medication can reduce the need for intubation in the first 72 hours of life.

Phospholipid Fraction, Porcine Lung

What is already known about the treatment

Exogenous Pulmonary Surfactant – This medication is administered intratracheally, meaning it is delivered directly into the trachea, typically in a hospital setting. It is currently used in medical practice and literature for treating premature infants with Respiratory Distress Syndrome (RDS). The main therapeutic indication is to reduce the surface tension in the lungs, helping them to expand more easily and improving breathing in these infants. At the molecular level, it works by replacing or supplementing the natural surfactant that is deficient in premature infants, thus aiding in lung function. It is classified pharmacologically as a pulmonary surfactant.

Investigated diseases

Respiratory Distress Syndrome in Premature Infants – This condition occurs in newborns, particularly those born prematurely, due to underdeveloped lungs. The primary issue is a deficiency of pulmonary surfactant, a substance that helps keep the air sacs in the lungs open. Without enough surfactant, the lungs struggle to expand, leading to breathing difficulties. Symptoms typically appear shortly after birth and include rapid, shallow breathing and a grunting sound during exhalation. The condition can progress quickly, requiring medical intervention to support breathing. The severity of the syndrome often correlates with the degree of prematurity.