Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Efficacy and safety of the intratracheal administration of budesonide with surfactant in very preterm infants to prevent bronchopulmonary dysplasia: randomized clinical trial.

This research is investigating a new way to help very premature babies (born at 32 weeks or less) avoid a serious lung condition called bronchopulmonary dysplasia, or BPD. Doctors are giving a steroid medicine called budesonide, along with a protective substance called surfactant, directly into the babies' windpipes. The main goal is to find out if this treatment is effective in preventing BPD and if it's safe for these fragile infants. They will be carefully checking the babies' lungs using special scans and looking for any potential side effects. The study also aims to understand how this treatment might affect the babies' health and development over their first two years of life.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer

Enrolment target

Start

08 Jan 2025

Bronchopulmonary dysplasia Preterm newborns ≤32 weeks of gestational age.

What is this study about?

This clinical trial is designed to help very premature babies who are born at 32 weeks of pregnancy or earlier. Premature babies often have underdeveloped lungs, which can lead to a long-term lung condition called bronchopulmonary dysplasia (BPD). BPD can make it hard for babies to breathe and may require them to stay on oxygen or breathing machines for longer.

In this study, doctors are giving a medicine called budesonide, which is a type of steroid, directly into the babies' lungs. They are giving it alongside another important substance called surfactant, which naturally helps lungs work better. The idea is that these medicines might help protect the delicate lungs of premature babies and stop BPD from developing or becoming severe. Researchers will be carefully observing how well the treatment works and if there are any side effects.

This is a 'Phase III' study, which means it's a very important step to confirm if this treatment is both effective and safe before it might be considered for wider use. It's about finding better ways to support the health and long-term well-being of our most vulnerable newborns. Researchers will follow the babies' health and development for two years to understand the full impact of the treatment.

Key takeaways

Targets premature babies to prevent lung disease (BPD).
Involves a steroid (budesonide) and surfactant given into the lungs.
Aims to check if the treatment is effective and safe.
Includes monitoring lung health and overall development.
Follows babies for two years to assess long-term effects.

Who may be eligible?

This study is for very premature babies. Specifically, it includes babies born at or before 32 weeks of pregnancy. Both baby boys and baby girls can take part.

There are no specific age limits beyond being a newborn premature baby, and the study doesn't exclude anyone based on sex. The doctors will determine if a baby fits all the specific health criteria for joining the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is my baby born at 32 weeks of pregnancy or earlier?
Is my baby a newborn?
Do doctors say my baby has no other immediate health issues that would prevent participation?

Answer every question to see your result.

What does participation involve?

If your baby takes part in this study, doctors will give them the study medicine (budesonide with surfactant) by gently putting it into their windpipe. They will then closely monitor your baby's health. This involves regular lung ultrasounds (like a scan to look inside the lungs) on various days, as well as checking samples from their nose to measure certain chemicals.

Doctors will also keep a close eye on your baby for any infections or other health problems. They will track how long your baby needs oxygen or breathing support. The study will continue to check on your baby's progress for their first two years. This includes looking at their general development (like how they learn, move, and talk) around age two, and checking their breathing health at the same time. The full duration of follow-up for each baby will be two years.

Potential risks and benefits

Taking part in a study like this could potentially offer your baby a chance at a new treatment that might help prevent serious lung problems. However, like all medicines and medical procedures, there can be risks. Researchers will be carefully watching for any infections, stomach problems, or other side effects, and will monitor babies very closely. You have the right to withdraw your baby from the study at any time, for any reason, without it affecting their medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What is BPD?

BPD stands for bronchopulmonary dysplasia. It's a long-term lung problem that can affect premature babies, making it harder for them to breathe and sometimes needing oxygen or breathing machines.

What is budesonide?

Budesonide is an anti-inflammatory medicine, a type of steroid, that's often used to help with breathing problems. In this study, it's given directly into the baby's lungs.

What is surfactant?

Surfactant is a natural substance in the lungs that helps them work properly. Premature babies might not have enough, so giving it to them can help their breathing.

Will my baby need extra tests?

Yes, your baby will have regular lung ultrasounds and samples taken from their nose to help doctors understand how the treatment is working.

How long does the study last?

The study involves following your baby's health and development until they are two years old.