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.
Studieöversikt
Status
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Sicily
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Palermo, Sicily, Italien, 90146
- Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
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.
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
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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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Electronic nose measurements
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Fraction of Exhaled Nitric Oxide (FeNO)
Tidsram: 1 week
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1 week
|
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Pulmonary function (FEV1, FVC, etc.)
Tidsram: 1 week
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1 week
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Samarbetspartners och utredare
Samarbetspartners
Publikationer och användbara länkar
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
- 5/2016
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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