RecruitingNAINTERVENTIONAL

Less Invasive Surfactant Administration in Late Preterm or Early Term Born Infants

This research is about helping babies born between 2 and 6 weeks early who struggle with their breathing right after birth. Many of these babies need help with breathing, and sometimes that means using a machine called a ventilator, which can have its own risks. We're investigating a gentler method called "Less Invasive Surfactant Administration" (LISA). Surfactant is a natural substance that helps keep tiny air sacs in the lungs open. In this study, we're giving artificial surfactant through a small tube while the baby is awake and already receiving oxygen through soft nasal tubes. The main goal is to see if this LISA treatment can reduce the number of babies who end up needing a ventilator, as well as looking at their length of stay in the hospital and their lung function.

At a glance

Status

Recruiting

Phase

Sponsor

King's College Hospital NHS Trust

Enrolment target

245

Start

08 May 2024

Estimated completion

01 Sep 2027

Respiratory Distress Syndrome Preterm Pregnancy Surfactant Deficiency Syndrome Neonatal

What is this study about?

When babies are born a little early, especially between 2 and 6 weeks before their due date, their lungs might not be fully ready to work on their own. This can lead to breathing difficulties because they might not have enough of a special substance called surfactant. Surfactant acts like a natural lubricant, helping the tiny air sacs in the lungs stay open, making it much easier to breathe.

Doctors often help these babies breathe using different methods. Sometimes, they need a breathing machine called a ventilator, but using a ventilator can sometimes lead to other problems like infections or damage to the lungs. Because of this, doctors prefer to use gentler ways to help babies breathe when possible. One of these gentler methods is called "high-flow nasal cannula" (HFNC), where warmed, moist air and oxygen are given through soft tubes placed in the baby's nose.

This study is looking at a new technique called "Less Invasive Surfactant Administration" (LISA). It involves giving artificial surfactant to babies who are already receiving HFNC. The surfactant is delivered through a very small, soft tube that is gently placed into the baby's windpipe through their mouth, while they are awake. The aim is to see if giving surfactant this way, while avoiding a full breathing machine, can help these babies breathe better and prevent them from needing more invasive support from a ventilator. We'll also be checking how long babies need to stay in the hospital and how well their lungs are working.

Key takeaways

This study helps babies born 2-6 weeks early with breathing issues.
It tests a gentle way to give lung medicine (surfactant) without a full breathing machine.
The goal is to reduce the need for ventilators, which have more risks.
Babies receive either the new treatment or standard oxygen therapy.
Researchers will check hospital stay length, lung function, and costs.

Who may be eligible?

This study is looking for babies born a little early, specifically between 34 and 38 weeks of pregnancy. This means babies born between about 2 and 6 weeks before their due date.

To be included, babies need to be breathing on their own and have a good heart rate shortly after birth, even if they need some initial help. They also need to be less than 24 hours old and show signs of breathing difficulty, meaning they need extra oxygen or are working hard to breathe, and the medical team has decided they need help with breathing that isn't a full breathing machine.

Babies cannot take part if they needed a breathing tube right after birth, or if they have any serious health problems or birth defects.

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.

My baby was born between 34 and 38 weeks of pregnancy (2 to 6 weeks early).
My baby is less than 24 hours old.
My baby is having some breathing difficulties, needing extra oxygen or working hard to breathe.
My baby was not put on a breathing tube right after birth.
My baby does not have any serious birth defects or other major health problems.

Answer every question to see your result.

What does participation involve?

If your baby takes part in this study, they will either receive the less invasive surfactant treatment during their high-flow nasal cannula (HFNC) oxygen therapy, or they will continue with only HFNC therapy. The decision on which group your baby is in will be made randomly, like flipping a coin.

During the study, doctors will closely monitor your baby's breathing and overall health. This includes checking their oxygen levels and how hard they are working to breathe. If your baby receives surfactant, it will be given through a small tube inserted gently into their windpipe while they are awake and receiving HFNC. Doctors will also measure your baby's lung function before and after the treatment. We will track how long your baby stays in the neonatal unit and any breathing support they need. The total duration of your baby's participation will mainly involve their time in the hospital, and close monitoring will continue for the first 72 hours.

Potential risks and benefits

Participating in this study might offer a potential benefit if the less invasive surfactant treatment reduces your baby's need for a full breathing machine, which carries its own risks. It could also potentially lead to a shorter hospital stay. However, there's also a chance the treatment might not help, or it could have minor side effects, though giving surfactant this way is generally considered safe. You are free to withdraw your baby from the study at any time, for any reason, without affecting their medical care.

Locations (1)

King's College Hospital
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is surfactant?

Surfactant is a natural substance in the lungs that helps the tiny air sacs stay open, making it easier to breathe. Babies born early might not have enough of it.

What is 'less invasive surfactant administration' (LISA)?

LISA is a gentle way to give surfactant to a baby. A small tube is put into the windpipe through the mouth while the baby is awake and already receiving breathing support, avoiding the need for a full breathing machine.

What is high-flow nasal cannula (HFNC)?

HFNC is a type of breathing support where a machine delivers warmed, moist oxygen and air through soft tubes placed in a baby's nose.

Why is avoiding a breathing machine (ventilator) important?

While ventilators can save lives, they can sometimes cause problems like infections or lung injury. Gentler methods are preferred when possible.

Will my baby definitely get the new treatment?

No, your baby will be randomly assigned to either receive the less invasive surfactant treatment or continue with standard high-flow nasal cannula therapy. It's like flipping a coin.

How to find out more

Eleanor Jeffreys, MBBS

eleanor.jeffreys@nhs.net +447519 974813 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.