AuthorisedTherapeutic use (Phase IV)Interventional

Premedication for Less Invasive Surfactant Administration (LISA-Med)

This study is called LISA-Med and focuses on helping premature babies who have trouble breathing, a condition called respiratory distress syndrome. These babies often need a treatment called LISA (Less Invasive Surfactant Administration), which involves giving them a special lung medicine called surfactant. The study is checking if giving babies a small amount of pain medicine before the LISA procedure can make it safer and more comfortable for them. They are watching closely for any issues that might come up during the procedure, like changes in heart rate, blood pressure, or oxygen levels. This is a Phase IV study, meaning the medicines used are already approved and often used, but researchers are gathering more information about their use together in this specific situation.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Pohjois-Pohjanmaan hyvinvointialue, University Of Oulu

Enrolment target

Start

28 Jan 2025

respiratory distress syndrome surfactant treatment premedication

What is this study about?

This study is looking at how we can make a common treatment safer and more comfortable for very tiny babies. These babies, often born prematurely, sometimes struggle to breathe on their own because their lungs aren't fully developed. This condition is called respiratory distress syndrome. A helpful treatment for this is called LISA, which stands for Less Invasive Surfactant Administration. This is where doctors carefully deliver a special medicine, called surfactant, directly into the baby's lungs to help them work better.

Because babies can get a bit stressed during medical procedures, even gentle ones like LISA, doctors sometimes give them medicine beforehand to help them relax and reduce any discomfort. This study, called LISA-Med, is specifically looking at giving pain relief medicines, Fentanyl and Ketamine, to babies just before the LISA procedure. The main goal is to see if giving these medicines helps prevent any problems from happening during LISA, such as big changes in the baby's heart rate, blood pressure, or breathing.

Researchers will be carefully monitoring the babies during and after the procedure to see how they respond. They're also interested in how long the procedure takes and how many attempts it takes to get the medicine into the right place. This information will help doctors understand the best way to care for these fragile babies.

Key takeaways

Study looks at medication before a lung treatment for babies.
Aims to make the treatment safer and more comfortable for infants.
Uses existing, approved pain relief medicines.
Doctors will carefully monitor babies throughout the procedure.
Helps improve care for babies with breathing difficulties.

Who may be eligible?

This study is open to both male and female babies, regardless of their age. The study is specifically for babies who need a treatment called LISA (Less Invasive Surfactant Administration) because they are having trouble breathing due to respiratory distress syndrome.

Because this is a study looking at how medicines work in very young children, there will be careful checks by the medical team to make sure it's the right fit for each baby. They'll consider the baby's overall health and specific needs.

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 your baby a new-born?
Does your baby have breathing problems due to undeveloped lungs?
Is your baby scheduled to have the LISA treatment?
Are you considering options for your baby's comfort during medical procedures?

Answer every question to see your result.

What does participation involve?

If your baby takes part in this study, they will receive either Fentanyl or Ketamine just before their planned LISA procedure. The doctors and nurses will closely monitor your baby's vital signs, like their heart rate, breathing, oxygen levels, and blood pressure, throughout the procedure. They will also note how long the procedure takes and how many attempts are needed to place the small tube for the surfactant medicine. The medical team will continue to observe your baby for any changes afterward, as they would with any standard medical care. The duration of their participation will primarily be during the LISA procedure itself and the immediate recovery period, as part of their ongoing hospital care.

Potential risks and benefits

Taking part in this study could potentially offer benefits by helping doctors understand better ways to make the LISA procedure more comfortable and safer for babies. The medicines used (Fentanyl and Ketamine) are already commonly used in hospitals to help with pain and sedation, but like all medicines, they can have side effects. Doctors will be watching very closely for any changes in your baby's condition, such as changes in heart rate or breathing. 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
Finland

Common questions

What is 'respiratory distress syndrome'?

It's a breathing problem common in premature babies because their lungs aren't fully developed and struggle to work properly.

What is 'LISA' treatment?

LISA is a gentle way to give a special lung medicine, called surfactant, directly into a baby's lungs to help them breathe better.

Why would my baby get medicine beforehand?

This study is looking at whether giving pain relief medicine before the LISA procedure helps make it smoother and more comfortable for the baby.

Are the medicines new or experimental?

No, the medicines (Fentanyl and Ketamine) have been used in hospitals for a long time, but this study looks at their specific use for this procedure.

What if I change my mind about my baby participating?

You can decide to withdraw your baby from the study at any point, and it won't affect their medical care or treatment.