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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
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Montpellier, France, 34295
- University Hospital of Montpellier, Arnaud de Villeneuve
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Preschool aged children detected of CF in neonatal period
Preschool aged children detected of Cystic Fibrosis in neonatal period
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Time evolution of functional residual capacity by Helium dilution technique (CRF He)
Délai: at each four yearly routine visits
|
at each four yearly routine visits
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
airway resistance by debit interruption technique (Rint)
Délai: at each four yearly routine visits
|
at each four yearly routine visits
|
|
|
plethysmographic measure of specific resistance (sRaw)
Délai: at each four yearly routine visits
|
at each four yearly routine visits
|
|
|
arterial blood gas measurement
Délai: at each four yearly routine visits
|
at each four yearly routine visits
|
|
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pulmonary clearance index
Délai: at each four yearly routine visits
|
at each four yearly routine visits
|
|
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flow-volume curve
Délai: at each four yearly routine visits
|
at each four yearly routine visits
|
|
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measurement of organ damage
Délai: at each four yearly routine visits
|
at each four yearly routine visits
|
|
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measurement of tobacco exposition
Délai: at each four yearly routine visits
|
at each four yearly routine visits
|
|
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measure of administration antibiotics and antiasthmatics treatments
Délai: at each four yearly routine visits
|
Comparison of the evolution of these parameters to changing those of a historical cohort evaluated before the introduction of neonatal screening.
|
at each four yearly routine visits
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: MATECKI SM Stephan, MD, University Hospital, Montpellier
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 9393
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