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Recruiting NCT05051254

NCT05051254 Respiratory Muscles and Work of Breathing in Children

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Clinical Trial Summary
NCT ID NCT05051254
Status Recruiting
Phase
Sponsor Assistance Publique - Hôpitaux de Paris
Condition Neuromuscular Diseases
Study Type INTERVENTIONAL
Enrollment 550 participants
Start Date 2022-01-19
Primary Completion 2028-01

Eligibility & Interventions

Sex All sexes
Min Age 0 Years
Max Age 17 Years
Study Type INTERVENTIONAL
Interventions
Esogastric pressure measurement

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 550 participants in total. It began in 2022-01-19 with a primary completion date of 2028-01.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

Respiratory muscle testing allows a quantitative assessment of inspiratory and expiratory muscles in children of any age with primary or secondary respiratory muscle impairment, in order to better understand the pathophysiology of respiratory impairment and guide therapeutic management. The use of an invasive technique (esogastric probe) makes it possible to specifically explore the diaphragm, the accessory inspiratory muscles and the expiratory muscles in order to detect dysfunction or paralysis of these muscles, and to estimate the work of breathing in order to better guide the respiratory management. The primary objective of the study is to evaluate the respiratory effort in children with primary or secondary impairment of the respiratory muscles during spontaneous breathing or during mechanical ventilation.

Eligibility Criteria

Inclusion Criteria: * Patients aged less than 18 years old with primary or secondary impairment of respiratory muscles and followed at Necker Hospital * Patients under spontaneous breathing or noninvasive or invasive mechanical ventilation * Written informed consent Exclusion Criteria: * No social insurance * Significant psychomotor retardation * Absence of cooperation * Significant agitation * Hemodynamic instability * Acute condition or temporary drug treatments that may interfere with the results of the respiratory muscle explorations

Contact & Investigator

Central Contact

Brigitte FAUROUX, MD, PhD

✉ brigitte.fauroux@aphp.fr

📞 1 71 19 60 92

Principal Investigator

Brigitte FAUROUX, MD, PhD

PRINCIPAL INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Frequently Asked Questions

Who can join the NCT05051254 clinical trial?

This trial is open to participants of all sexes, aged 0 Years or older, up to 17 Years, studying Neuromuscular Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT05051254 currently recruiting?

Yes, NCT05051254 is actively recruiting participants. Contact the research team at brigitte.fauroux@aphp.fr for enrollment information.

Where is the NCT05051254 trial being conducted?

This trial is being conducted at Paris, France.

Who is sponsoring the NCT05051254 clinical trial?

NCT05051254 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Brigitte FAUROUX, MD, PhD at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 550 participants.

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