Within-day and Between-day Repeatability of the Breath Pattern in Healthy Children and in Children With Asthma (CERS)
Within-day and Between-day Repeatability of the Breath Pattern in Healthy Children and in Children With Moderate Asthma
"Within-day and Between-day Repeatability of the Breath Pattern in Healthy Children and in Children With Moderate Asthma" is an observational prospective study in outpatient clinic of Pediatric Allergology & Pulmonology (PAP) within the Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (IBIM CNR), Italy.
The electronic nose (E-nose) has been proposed as a novel, non-invasive tool to evaluate the level of airway inflammation for different respiratory diseases, especially in children. To date, there are no data on the within-day and the between-day repeatability of the breath pattern in healthy children and in children with moderate asthma.
The breath pattern will be analyzed by collecting, for each child, three samples of the breath through the E-nose. Within-day repeatability will be assessed using two consecutive measurements (the second one after 30 minutes). Between-day repeatability will be assessed using a third measurement repeated after 7 days.
The study is expected to provide information about the accuracy of E-nose measurements for a child population.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Sicily
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Palermo, Sicily, Italië, 90146
- Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
A study population of 15 asthmatic children (moderate asthma) attending the outpatient clinic of Pediatric Allergology & Pulmonology (PAP) within the Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (IBIM CNR).
A control group of healthy children (n=30), recruited from the primary schools involved in the municipal project "educational pathways" (Palermo, Italy) to which the PAP group partecipates.
Beschrijving
The inclusion criteria for asthmatic children are:
- Moderate asthma (GINA 2015);
- Age 6-11 years;
- No upper airway respiratory infections or exacerbations in the last 4 weeks;
- Steroid-naive asthma;
- Positive bronchodilator response;
- Non smoker.
The inclusion criteria for healthy children are:
- Age 6-11 years;
- No upper airway respiratory infections in the last 4 weeks;
- Non smoker;
- No history of asthma and respiratory diseases during the life;
- Negative bronchodilator response.
The exclusion criteria are:
- Symptoms of acute respiratory infection;
- Immunological and metabolic systemic disease;
- Major malformations of the upper airways;
- Active smoker.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
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15 children with moderate asthma
Assessment of E-nose measurements: three E-nose measurements on 15 children with moderate asthma (of both sex and 6-11 years old): first measurement, second one after 30 minutes, third one after 7 days.
These children attend the outpatient clinic of Pediatric Allergology & Pulmonology (PAP) within the Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (IBIM CNR).
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Breath sampling through E-nose pneumopipe
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30 healthy children
Assessment of E-nose measurements: three E-nose measurements on 30 healthy children (of both sex and 6-11 years old): first measurement, second one after 30 minutes, third one after 7 days.
These children attend the primary schools involved in the municipal project "Educational Pathways" (Palermo).
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Breath sampling through E-nose pneumopipe
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Electronic nose measurements
Tijdsspanne: 1 week
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Several volatile organic compounds, including isoprene, 1,2-pentadiene, acetone, ethanol, pentane and ethane, identified in exhaled breath.
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1 week
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Fraction of Exhaled Nitric Oxide (FeNO)
Tijdsspanne: 1 week
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1 week
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Pulmonary function (FEV1, FVC, etc.)
Tijdsspanne: 1 week
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1 week
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Medewerkers en onderzoekers
Medewerkers
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 5/2016
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
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