- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Montpellier, Frankrike, 34295
- University Hospital of Montpellier, Arnaud de Villeneuve
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Preschool aged children detected of CF in neonatal period
Preschool aged children detected of Cystic Fibrosis in neonatal period
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Time evolution of functional residual capacity by Helium dilution technique (CRF He)
Tidsram: at each four yearly routine visits
|
at each four yearly routine visits
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
airway resistance by debit interruption technique (Rint)
Tidsram: at each four yearly routine visits
|
at each four yearly routine visits
|
|
plethysmographic measure of specific resistance (sRaw)
Tidsram: at each four yearly routine visits
|
at each four yearly routine visits
|
|
arterial blood gas measurement
Tidsram: at each four yearly routine visits
|
at each four yearly routine visits
|
|
pulmonary clearance index
Tidsram: at each four yearly routine visits
|
at each four yearly routine visits
|
|
flow-volume curve
Tidsram: at each four yearly routine visits
|
at each four yearly routine visits
|
|
measurement of organ damage
Tidsram: at each four yearly routine visits
|
at each four yearly routine visits
|
|
measurement of tobacco exposition
Tidsram: at each four yearly routine visits
|
at each four yearly routine visits
|
|
measure of administration antibiotics and antiasthmatics treatments
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: MATECKI SM Stephan, MD, University Hospital, Montpellier
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 9393
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