- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02358798
Respiratory Function at Preschool Age of Children Detected of Cystic Fibrosis in Neonatal Period (REVOLMUCO)
The widespread neonatal detection of cystic fibrosis in France since 2002 permits to treat children from birth. New treatments used for young children involve to assess efficacy criteria specific to this population. Standard respiratory function criteria for older children and adults is forced expiratory volume/second.
This technique is not suited for preschool aged children (3 to 6 years old) because they are too old to be sedated and too young and immature to be able to make forced expiration technique that are correct, reproducible and prolonged during more than 1 second.
For preschool aged children, in order to assess distal damage and her consequence, the evaluations are: airway resistance by debit interruption technic (Rint), plethysmographic measure of specific resistance (sRaw), functional residual capacity by Helium dilution technique (CRF He), arterial blood gas measurement, pulmonary clearance index.
All these methods have a better success rate and can be used in alternative or with forced spirometry. However, each of them gives only a part of information on airway and lung damage of detected children. It is necessary to combine them for a better information on overall respiratory damage.
In France, each respiratory function test laboratory uses one or any of these methods in addition to flow-volume curve, in function of his practices and his equipment.
So, respiratory function test of preschool aged children is going to diversify more and more to the detriment of an homogeneity of practices between different centers.
A referent population during a longitudinal multicenter monitoring on large cohorts that describe the evolution of pulmonary function, obtained by a standardized methodology is necessary to assess the efficacy of any new treatment. And, with the homogenization of care of children detected of cystic fibrosis in different centers, the description of natural evolution of pulmonary function by a standardized methodology will improve the discriminative power of measure of respiratory function to assess the presence of a worsening in preschool-aged children.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Montpellier, Francia, 34295
- University Hospital of Montpellier, Arnaud de Villeneuve
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Patient suffering from cystic fibrosis
- Height between 90 et 130cm
- No respiratory exacerbation since 4 weeks
- Benefit from an insurance disease regime
Exclusion Criteria:
- Law-protected patient
- Patient's parent don't understand french language
- Opposition to participation
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Preschool aged children detected of CF in neonatal period
Preschool aged children detected of Cystic Fibrosis in neonatal period
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Time evolution of functional residual capacity by Helium dilution technique (CRF He)
Lasso di tempo: at each four yearly routine visits
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at each four yearly routine visits
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
airway resistance by debit interruption technique (Rint)
Lasso di tempo: at each four yearly routine visits
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at each four yearly routine visits
|
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plethysmographic measure of specific resistance (sRaw)
Lasso di tempo: at each four yearly routine visits
|
at each four yearly routine visits
|
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arterial blood gas measurement
Lasso di tempo: at each four yearly routine visits
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at each four yearly routine visits
|
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pulmonary clearance index
Lasso di tempo: at each four yearly routine visits
|
at each four yearly routine visits
|
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flow-volume curve
Lasso di tempo: at each four yearly routine visits
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at each four yearly routine visits
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measurement of organ damage
Lasso di tempo: at each four yearly routine visits
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at each four yearly routine visits
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measurement of tobacco exposition
Lasso di tempo: at each four yearly routine visits
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at each four yearly routine visits
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measure of administration antibiotics and antiasthmatics treatments
Lasso di tempo: at each four yearly routine visits
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Comparison of the evolution of these parameters to changing those of a historical cohort evaluated before the introduction of neonatal screening.
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at each four yearly routine visits
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: MATECKI SM Stephan, MD, University Hospital, Montpellier
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 9393
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Prove cliniche su Fibrosi cistica
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National Institute of Allergy and Infectious Diseases...Completato