RecruitingNAINTERVENTIONAL

Optimising HFO&VTV in Newborn Infants

This research is about improving how we help newborn babies who need breathing support. We're looking at a type of ventilator called High Frequency Oscillation with Volume Targeted Ventilation (HFO&VTV). It's designed to deliver very small breaths quickly while aiming for a specific amount of air, which might be gentler on a baby's lungs and better for controlling carbon dioxide levels, potentially protecting their brain. Currently, there aren't clear guidelines for using HFO&VTV. This study aims to compare this new method with the standard HFO to check its safety for babies' brains and hearts, and to find the best settings to use. This could lead to safer and more effective breathing support for vulnerable newborns.

At a glance

Status

Recruiting

Phase

Sponsor

King's College Hospital NHS Trust

Enrolment target

Start

26 Feb 2025

Estimated completion

01 Sep 2026

High Frequency Oscillation Volume Targeted Ventilation

What is this study about?

When newborn babies, especially those born early, need help breathing, doctors often use a special machine called a ventilator. While ventilators are life-saving, they can sometimes cause problems. One type of ventilator is called High Frequency Oscillation (HFO), which helps babies breathe by giving tiny puffs of air very quickly. This can be less stressful on the lungs than traditional ventilators.

However, there's a newer version called High Frequency Oscillation with Volume Targeted Ventilation (HFO&VTV). This updated system tries to give a specific, gentle amount of air with each tiny puff. The main idea behind HFO&VTV is to protect the baby's delicate lungs even more, and to better control the levels of carbon dioxide in their blood. Too much or too little carbon dioxide can sometimes be a concern for a baby's brain health. Right now, doctors don't have clear instructions or 'guidelines' on how best to use this new HFO&VTV system.

This study wants to find out if HFO&VTV is safe for newborn babies compared to the standard HFO. We'll be looking carefully at how blood flows to the baby's brain and how well their heart is working. The study will also help us discover the ideal starting settings for this new ventilator. The goal is to provide doctors with clearer guidance so they can use this technology as safely and effectively as possible for the smallest and most vulnerable patients.

Key takeaways

This study evaluates a new, gentle ventilator setting for newborns.
It aims to find the safest settings for babies’ brains and hearts.
Participation involves short periods on different ventilator settings.
Monitoring includes non-invasive heart and brain scans (for full-term babies).
Your baby's care will not be affected if you choose not to participate.
The study could lead to better breathing support for future babies.

Who may be eligible?

This study is looking for newborn babies who are currently receiving breathing support using a high-frequency oscillatory ventilator. This includes babies born at any stage of pregnancy, from very premature to full-term.

However, some babies cannot take part. This includes babies who have certain known brain problems, such as a previous stroke, fluid on the brain (hydrocephalus), bleeding in the brain, or a serious brain injury caused by lack of oxygen shortly after birth. Also, babies with known heart defects that they were born with will not be able to join 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 a newborn?
Is my baby currently on a high-frequency oscillatory ventilator?
Does my baby have any known brain problems (like stroke or bleeding)?
Was my baby born with any heart problems?

Answer every question to see your result.

What does participation involve?

If your baby is eligible, the research team will explain the study and provide you with information. If you agree, you'll be asked to give your written permission. Your baby will stay on their usual high-frequency oscillatory ventilator. During the study, your baby will be switched to the new HFO&VTV settings for short periods, typically 10 to 20 minutes at a time, trying three different settings in a random order. Between these new settings, your baby will briefly return to their previous ventilator settings for about 20 minutes.

Throughout the study, we will monitor your baby's carbon dioxide levels using a stick-on sensor on their skin. Towards the end of each different ventilator setting period, doctors will perform a quick ultrasound scan of your baby's heart (a 'bedside echocardiogram') and, for full-term babies, an ultrasound scan of their brain. The total time your baby is actively involved in the study procedures will be a few hours, all while they are in their cot within the hospital and are already stable.

Potential risks and benefits

This study aims to find safer and more effective ways to support breathing in newborn babies, which could benefit many infants in the future. We will carefully monitor your baby throughout the study to ensure their safety. We will measure blood flow to the brain and heart function, which are standard, non-invasive procedures. It's important to remember that joining any study is completely voluntary, and you have the right to withdraw your baby at any time, for any reason, without it affecting their care.

Locations (1)

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

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

Common questions

What is a ventilator?

A ventilator is a machine that helps babies breathe when they are too unwell to breathe properly on their own.

What does 'high frequency oscillation' mean?

It's a special way a ventilator works, giving many very small, gentle breaths per minute instead of fewer, larger breaths.

Will my baby be given different medications?

No, this study is about adjusting ventilator settings, not about giving new medications.

How long will my baby be part of the study?

The active part of the study, where settings are changed and monitored, will take a few hours on a single day.

Will my baby be uncomfortable during the study?

The research team will ensure your baby is stable and comfortable. We will use scans that are generally well-tolerated by babies.

How to find out more

Ourania Kaltsogianni, MSc

ourania.kaltsogianni@nhs.net 0044+02032999000 Official trial record

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