RecruitingNAINTERVENTIONAL

Respiratory Muscles and Work of Breathing in Children

This study focuses on understanding how well breathing muscles work in children, especially those with conditions that affect these muscles. Doctors use a special, temporary tube placed gently in the food pipe and stomach to measure the strength of the main breathing muscle (the diaphragm) and other muscles used for breathing in and out. This helps the medical team understand why a child might be struggling to breathe, how hard they are working, and whether current treatments are helping. The aim is to get a clearer picture of their breathing challenges to better guide their care, whether they are breathing on their own or with the help of a machine.

At a glance

Status

Recruiting

Phase

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

550

Start

19 Jan 2022

Estimated completion

01 Jan 2028

Neuromuscular Diseases Congenital Diaphragmatic Hernia Lung Diseases Cardiac Diseases Scoliosis Diaphragmatic Impairment Respiratory Muscle Impairment

What is this study about?

This study aims to get a clearer picture of how well breathing muscles work in children. Many different health problems, like certain muscle conditions, heart or lung diseases, or curved spines, can make it harder for children to breathe properly. When doctors understand exactly how a child's breathing muscles are working, or if some are weak or not working correctly, they can choose the best ways to help.

To do this, we use a special, but temporary, measurement technique. A thin, flexible tube is gently placed through the nose into the food pipe (oesophagus) and stomach. This tube helps us measure the pressure inside the chest and stomach, which gives us information about how strong the main breathing muscle (the diaphragm) is, and how much effort other muscles are putting into breathing in and out. This can help identify when a muscle isn't working as it should, or if a child is working very hard to breathe.

By understanding these details, doctors can tailor treatments more effectively. For example, if a child is on a breathing machine, these measurements can help adjust the machine settings to be just right for them. It can also help show if a child is strong enough to come off the breathing machine. Sometimes, these measurements can also help assess if a new medicine is making breathing muscles stronger over time.

Key takeaways

Study focuses on children's breathing muscles.
Uses a special tube to measure breathing effort.
Helps doctors understand and guide treatment.
Aims to improve care for children with breathing difficulties.
Requires parental consent and child's cooperation.

Who may be eligible?

This study is looking for children under 18 years old who have problems with their breathing muscles, whether those problems are the main issue or have started because of another health condition. These children must already be receiving care at Necker Hospital and be either breathing on their own or using a breathing machine.

Before taking part, a parent or guardian would need to give their written permission and understand what the study involves. It's really important that the child is comfortable and able to cooperate during the measurements.

Children would not be able to join the study if they don't have health insurance, have significant learning or development difficulties, can't cooperate with the measurements, are very restless, or are currently very unwell or unstable. Children who are taking temporary medications that could affect their breathing muscle measurements would also not be able to join for safety and accuracy reasons.

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 under 18 years old?
Does your child have a known problem with their breathing muscles?
Is your child currently being treated at Necker Hospital?
Is your child able to cooperate with medical procedures?
Is your child stable and not acutely unwell?

Answer every question to see your result.

What does participation involve?

If your child takes part, a special flexible tube will be gently placed through their nose into their food pipe and stomach. This tube measures pressures related to their breathing muscles. There are no medications involved in this specific part of the study. The measurement is usually done during a standard medical assessment. The total time for the measurement itself is usually quite short, but preparations and observation would be part of a hospital visit. There is no set "duration" for the study participation, as it involves a measurement at a specific point in time, and potentially repeat measurements if your doctor feels it would be beneficial for your child's care to see how their breathing changes over time or with treatment.

Potential risks and benefits

Taking part in this study may help doctors gain a deeper understanding of your child's breathing muscle strength and effort, which could lead to more tailored and effective care. For example, it might help adjust breathing machine settings or assess improvements with treatment. While these measurements are generally safe, there's a small chance of discomfort when the tube is placed, or very rarely, minor irritation to the nose or throat. You have the right to withdraw your child from the study at any time without giving a reason, and this will not affect their medical care.

Locations (1)

Hôpital Necker-Enfants Malades
Verified postcode
Paris, France· Recruiting

Common questions

What is the main goal of this study?

The main goal is to understand how well children's breathing muscles work and how much effort they put into breathing, especially if they have conditions affecting these muscles.

How is breathing muscle strength measured?

Doctors use a special, temporary tube gently placed through the nose into the food pipe and stomach. This helps measure pressures to understand muscle strength and effort.

Is the measurement painful for my child?

Placing the tube can be a bit uncomfortable, but it's done gently and usually doesn't cause significant pain. The medical team will ensure your child is as comfortable as possible.

Can taking part help my child's treatment?

By giving doctors more detailed information about your child's breathing, the study can help them choose and adjust treatments more effectively, such as ventilator settings.

Who can join this study?

Children under 18 who have breathing muscle problems and are cared for at Necker Hospital, and who can cooperate with the measurement, may be eligible. Parents or guardians need to give permission.

How to find out more

Brigitte FAUROUX, MD, PhD

brigitte.fauroux@aphp.fr 1 71 19 60 92 Official trial record

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