RecruitingNAINTERVENTIONAL

Fluid-responsiveness in Children Ventilated With LOW Tidal Volume - The FLOW Study.

This study is about helping doctors decide if a child who is very sick and on a breathing machine needs more fluids. Sometimes, giving too many fluids can be harmful. We are testing a special ultrasound measurement called ΔVPeak. This measurement uses how breathing affects blood flow to help predict if giving fluids will improve a child's condition. While this test is already used, it hasn't been properly checked in children who are on a newer, gentler type of breathing support (called 'low tidal volume ventilation'). If it works, it could help doctors make better, safer decisions about fluid treatment, preventing unnecessary or harmful fluid overload in these vulnerable children.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Bordeaux

Enrolment target

Start

10 Nov 2025

Estimated completion

01 Nov 2027

Circulatory Failure (Shock)

What is this study about?

When children are very unwell, especially if their body isn't getting enough blood flow (doctors call this 'circulatory failure' or 'shock'), giving them extra fluids is a common treatment. However, it's a bit like watering a plant: too little and it withers, but too much can also cause problems, like watery lungs. So, doctors need a good way to know if giving more fluids will actually help a child, or if it might even make things worse.

This study focuses on a special test called ΔVPeak. It uses an ultrasound (like the scans used during pregnancy) to look at how blood flows from the heart. What's clever about it is that it watches how the child's breathing on a machine affects this blood flow. This gives doctors a clue about whether giving fluids will boost their heart's performance and improve their condition. This test has been used before, but mainly in children on older types of breathing machines with higher 'tidal volumes' (how much air goes into the lungs with each breath). Nowadays, doctors often use a gentler approach with 'low tidal volume' breathing machines to protect the lungs.

So, the main goal of this study is to check if the ΔVPeak test still works well and gives accurate information in children who are on these newer, gentler breathing machines. If it does, it could become a simple and quick tool for doctors in intensive care units to make safer and more effective decisions about giving fluids, helping these sick children get better without the risk of too much fluid.

Key takeaways

This study aims to make fluid treatment safer and more effective for sick children.
It tests a special ultrasound method to guide fluid decisions in children on breathing machines.
The focus is on children using modern, gentler breathing support.
Participation involves no extra procedures, just observations during routine care.
It could improve care for children needing critical support in the future.

Who may be eligible?

This study is for children aged from newborns up to 15 years old who are in a children's intensive care unit. To be included, the child must be on a breathing machine set to a specific gentle level (called 'low tidal volume') and the doctor treating them must have decided that they need extra fluids because their body isn't getting enough blood flow.

However, there are reasons why a child might not be able to join. For example, if they were born very prematurely, have certain heart rhythm problems, are in a position that makes the ultrasound hard to do, are on a special heart-lung support machine, or have other specific heart or lung conditions. Also, if there's any reason that waiting a few minutes for the test would be unsafe for the child, they wouldn't be included. We also wouldn't include children whose parents or legal guardians don't want them to take part.

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 child between newborn and 15 years old?
Is your child currently in a children's intensive care unit?
Is your child on a breathing machine set to a 'low tidal volume' (gentler) setting?
Has your child's doctor decided extra fluids are needed due to poor circulation?
Does your child have any conditions like severe prematurity or certain heart rhythm problems?

Answer every question to see your result.

What does participation involve?

If your child is eligible for this study, there are no extra appointments or medications involved. The study simply involves the doctors using an ultrasound test called ΔVPeak, which is already a normal part of care in the intensive care unit. This test helps them decide if your child needs fluids. They will perform this test and then, if appropriate, your child will receive the extra fluids as planned by their doctor. They will then do another quick scan to see how the fluids have helped. This simply means that the timing of the next steps in your child's treatment might be paused for a few minutes (less than 3 minutes) while the test is done. The total duration of your child's involvement in the study itself is only those few minutes while the tests are conducted as part of their routine care.

Potential risks and benefits

There are no direct benefits to your child from taking part in this research study, as the doctors are already using the ultrasound and deciding on fluids as part of their standard care. However, the information gathered from this study could help future children by improving how doctors decide on fluid treatment. There are no additional risks to your child beyond the usual care they would receive, as the test is non-invasive and the treatment decisions remain with their medical team. The study involves a very short delay (less than 3 minutes) in administering fluids, but this delay is only for cases where it is safe to do so. You are free to withdraw your child from the study at any time without it affecting their care.

Locations (6)

CHU d'Amiens Picardie
Verified postcode
Amiens, France· Recruiting
CHU de BORDEAUX
Verified postcode
Bordeaux, France· Recruiting
CHU de LIMOGES
Verified postcode
Limoges, France· Recruiting
Hôpital Necker-Enfants Malades
Verified postcode
Paris, France· Recruiting
Hôpital Robert Debré
Verified postcode
Paris, France· Recruiting
CHU de Rouen Normandie
Verified postcode
Rouen, France· Recruiting

Common questions

What is 'circulatory failure'?

It means your child's body isn't getting enough blood flow, which can affect how their organs work. It's also sometimes called 'shock'.

What is a 'breathing machine'?

It's a machine that helps your child breathe if they are too sick to do it on their own completely. This study is specifically for children on a 'gentler' setting of the machine.

What is the ΔVPeak test?

It's a special ultrasound scan that looks at how blood flows from the heart and how that flow changes with each breath. It helps doctors guess if more fluids would help your child.

Will my child get different treatment in this study?

No, your child will receive fluids if their doctor thinks they need them, just as they would normally. The study just helps us understand if the test works well to guide those decisions.

How long does taking part last?

The study part only involves a few extra minutes of observation during your child's routine care in the intensive care unit.

How to find out more

Julien GOTCHAC, MD

julien.gotchac@chu-bordeaux.fr 0556795913 Official trial record

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