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Comparing 1-Minute and 5-Minute Poractant Alfa Treatment for Respiratory Distress Syndrome in Very Premature Babies Born Before 28 Weeks

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What is this trial about?

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

This study looks at neonatal respiratory distress syndrome, which is a breathing problem that can occur in babies born very early, before their lungs are fully developed. The study uses a treatment called poractant alfa, which is a type of lung medicine known as surfactant. Surfactant is a natural substance that helps keep the air sacs in the lungs open so babies can breathe more easily. When babies are born too early, their lungs may not make enough of this substance on their own, which makes breathing difficult. The medicine is given directly into the lungs through a thin tube using a method called LISA, which stands for less invasive surfactant administration.

The purpose of the study is to find out whether the length of time it takes to give the surfactant medicine affects how well very premature babies maintain their vital signs, such as oxygen levels in the blood, heart rate, and oxygen levels in the brain. The study will compare two different ways of giving the medicine: one group will receive it over one minute, and another group will receive it over five minutes. Doctors want to see if one method works better than the other in keeping these important body measurements stable. The babies in this study are born at less than 28 weeks of pregnancy, which means they are very premature and need special care in the first days after birth.

During the study, babies will be watched closely for the first three hours after receiving the surfactant treatment, and then continuing observations will be made during their hospital stay. The medical team will measure things like oxygen levels, heart rate, and blood pressure to see how the babies respond to the treatment. They will also check whether babies need extra oxygen, whether they experience any drops in heart rate or oxygen levels, and whether they need a second dose of surfactant. The study will also look at whether babies need help from a breathing machine in the first two days after treatment and will follow their overall health until they go home from the hospital or reach their original due date, whichever comes first.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment and randomization
Your baby will be enrolled in the study within the first 72 hours after birth.
Your baby will be randomly assigned to one of two groups: either the 1-minute group or the 5-minute group. This determines how long the surfactant treatment will be given.
Step 2
Surfactant administration
Your baby will receive surfactant, a substance that helps the lungs work properly, using a method called LISA (less invasive surfactant administration).
The surfactant is called poractant alfa and is given directly into the lungs through a thin tube inserted into the windpipe.
Depending on the group your baby is assigned to, the surfactant will be given over either 1 minute or 5 minutes.
The available doses are 120 mg or 240 mg, depending on your baby's weight and medical needs.
Step 3
Monitoring during surfactant administration
During the surfactant administration and for 15 minutes afterwards, your baby's vital signs will be closely monitored.
These vital signs include oxygen levels in the blood (SpO2), heart rate (HR), and oxygen levels in the brain tissue (crSO2).
The medical team will observe any changes in these measurements from the moment the thin tube is inserted until 15 minutes after the procedure is completed.
Step 4
Extended monitoring period
After the surfactant is given, your baby's vital signs will continue to be monitored for up to three hours.
The measurements include oxygen levels in the blood (SpO2), heart rate (HR), oxygen levels in the brain tissue (crSO2), and blood pressure (MABP).
The medical team will check these vital signs every five minutes during this period.
The amount of extra oxygen your baby needs, as well as any episodes of slow heart rate or low oxygen levels, will be recorded.
Step 5
Assessment of additional treatment needs
The medical team will assess whether your baby needs a second dose of surfactant.
During the first two days after the initial surfactant treatment, it will be recorded if your baby requires invasive ventilation, which means breathing support through a tube placed in the windpipe.
Step 6
Long-term observation until discharge
Your baby will be observed for overall health outcomes until either discharge from the hospital or until reaching the equivalent of full-term age, whichever occurs first.
This observation includes monitoring for any complications or health issues related to prematurity and the respiratory condition.

Who can join the trial?

3 criteria

The baby must be born before completing 28 weeks of pregnancy, which means up to 27 weeks and 6 days. This is called a preterm neonate, meaning a baby born much earlier than the usual 40 weeks.
The baby must need a treatment called surfactant, which is a medicine that helps the baby's lungs work better. This medicine must be given using a specific method called LISA, which stands for a gentle way of delivering the medicine through a thin tube.
The baby must be less than 72 hours old, which means the treatment happens within the first three days after birth.

Who cannot join the trial?

1 criterion

No specific exclusion criteria have been provided for this clinical trial in the available information.

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Medical University Of Graz
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Graz, Austria

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Investigated drugs

Surfactant is a substance that helps the lungs work properly. In premature babies, the lungs may not produce enough surfactant on their own, which makes breathing difficult. This medication is given directly into the baby's lungs through a thin tube to help the air sacs in the lungs stay open and make breathing easier. In this trial, doctors are studying how long it takes to give this medication and how it affects the baby's oxygen levels, heart rate, and blood flow to the brain.

Poractant Alfa

What is already known about the treatment

Surfactant – Surfactant is a medication given directly into the lungs through a thin tube to help premature babies breathe more easily when their lungs are not fully developed. It is a well-established treatment used worldwide for respiratory distress syndrome in newborns, particularly those born very early. The medication works by reducing surface tension in the tiny air sacs of the lungs, preventing them from collapsing and making it easier for the baby to breathe on their own. Surfactant belongs to a class of medications called pulmonary surfactants, which replace the natural substance that premature infants lack in their underdeveloped lungs.

Investigated diseases

Neonatal Respiratory Distress Syndrome – Neonatal respiratory distress syndrome is a breathing disorder that affects newborn babies, especially those born prematurely. The condition occurs because the baby's lungs are not fully developed and lack sufficient surfactant, a substance that helps keep the air sacs in the lungs open. Without enough surfactant, the tiny air sacs collapse, making it difficult for the baby to breathe and get enough oxygen. Symptoms typically appear shortly after birth and include rapid, shallow breathing, grunting sounds while breathing, flaring of the nostrils, and a bluish color of the skin due to low oxygen levels. The condition is most common in babies born before 28 weeks of pregnancy, as their lungs have not had enough time to produce adequate amounts of surfactant. As the baby's lungs mature and begin producing more surfactant, breathing gradually becomes easier.