- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Montpellier, Frankrike, 34295
- University Hospital of Montpellier, Arnaud de Villeneuve
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Preschool aged children detected of CF in neonatal period
Preschool aged children detected of Cystic Fibrosis in neonatal period
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Time evolution of functional residual capacity by Helium dilution technique (CRF He)
Tidsramme: at each four yearly routine visits
|
at each four yearly routine visits
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
airway resistance by debit interruption technique (Rint)
Tidsramme: at each four yearly routine visits
|
at each four yearly routine visits
|
|
plethysmographic measure of specific resistance (sRaw)
Tidsramme: at each four yearly routine visits
|
at each four yearly routine visits
|
|
arterial blood gas measurement
Tidsramme: at each four yearly routine visits
|
at each four yearly routine visits
|
|
pulmonary clearance index
Tidsramme: at each four yearly routine visits
|
at each four yearly routine visits
|
|
flow-volume curve
Tidsramme: at each four yearly routine visits
|
at each four yearly routine visits
|
|
measurement of organ damage
Tidsramme: at each four yearly routine visits
|
at each four yearly routine visits
|
|
measurement of tobacco exposition
Tidsramme: at each four yearly routine visits
|
at each four yearly routine visits
|
|
measure of administration antibiotics and antiasthmatics treatments
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: MATECKI SM Stephan, MD, University Hospital, Montpellier
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 9393
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Cystisk fibrose
-
National Institute of Allergy and Infectious Diseases...Fullført
Kliniske studier på 3 years-assessment of respiratory function
-
Memorial Sloan Kettering Cancer CenterUniversity of Texas Southwestern Medical Center; Wake Forest UniversityAktiv, ikke rekrutterende
-
University Medical Centre LjubljanaUniversity of Ljubljana, Faculty of Medicine; National Institute of Chemistry... og andre samarbeidspartnereFullførtCTNNB1-genmutasjonSlovenia, Australia
-
University Health Network, TorontoHar ikke rekruttert ennåSmertebehandlingCanada