NCT05051254|Recruiting
Respiratory Muscles and Work of Breathing in Children
WOB&MR_Ped
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WOB&MR_Ped
Sponsor study identifier
Secondary identifiers
OTHER · ID RCB Number
interventional
550
1 country
1
Study Start
January 19, 2022
Actual (reported)Primary Completion
January 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 14, 2021
Actual (reported)September 21, 2021
Actual (reported)January 19, 2022
Actual (reported)January 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
January 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Esophageal pressure-time product (PTPoes)
The integral of the esophageal pressure signal over inspiratory time
Day 0
Diaphragmatic pressure-time product (PTPdi)
The integral of the transdiaphragmatic pressure signal over inspiratory time
Day 0
Work of breathing (WOB)
Total work of breathing (WOBt) is calculated (in Joules/L) as the area under the pressure-volume curve, using the Campbell diagram. Elastic (WOBe) and resistive (WOBr) are estimated as the 2/3 and 1/3 of WOBt value, respectively.
Day 0
Minor patients with primary or secondary impairment of respiratory muscles and followed at Necker Hospital
Measurement of work of breathing and respiratory muscles strength using an esogastric catheter. One measurement or before and after (6 months and 1 year) the initiation of a pharmacological treatment in order to assess the effect of the treatment on respiratory muscle function.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Hôpital Necker-Enfants Malades
Paris, 75015, France
Brigitte FAUROUX, MD, PhD
Assistance Publique - Hôpitaux de Paris
Sonia KHIRANI, PhD
Assistance Publique - Hôpitaux de Paris
First Submitted
June 14, 2021
First Posted
September 21, 2021
Study Start
January 19, 2022
Actual (reported)Primary Completion
January 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Functional Evaluation of the Fetal Lung by Functional Magnetic Resonance Imaging - Blood Oxygenation Level Dependent (MRI-BOLD), in Congenital Diaphragmatic and Parietal Malformations
Vital capacity
Day 0
Maximal respiratory static pressures
Day 0
Maximal sniff pressure
Day 0
Maximal whistle pressure
Day 0
Peak expiratory flow
Day 0
Contact the study team to confirm eligibility.
Study Completion
January 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 3, 2026
Record last verified: 2026-03
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Source: ClinicalTrials.gov.
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