An observational study in Asthma and Healthy, sponsored by Istituto per la Ricerca e l'Innovazione Biomedica. Completed at 1 site in Italy. Open to participants aged 6 Years to 11 Years. Per ClinicalTrials.gov, last updated 2018-09-05.
Sponsored by Istituto per la Ricerca e l'Innovazione Biomedica · Observational
"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.
3,920 studies on the registry are indexed under Asthma; 506 are open to participants now.
This study's enrollment of 45 is below the median of 150 across 970 observational studies indexed under Asthma.
Browse Asthma studies →Istituto per la Ricerca e l'Innovazione Biomedica is the lead sponsor of 46 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
The inclusion criteria for asthmatic children are:
The inclusion criteria for healthy children are:
The exclusion criteria are:
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).
Other: Assessment of E-nose measurements
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).
Other: Assessment of E-nose measurements
Breath sampling through E-nose pneumopipe
Electronic nose measurements
Several volatile organic compounds, including isoprene, 1,2-pentadiene, acetone, ethanol, pentane and ethane, identified in exhaled breath.
Time frame: 1 week
Fraction of Exhaled Nitric Oxide (FeNO)
Time frame: 1 week
Pulmonary function (FEV1, FVC, etc.)
Time frame: 1 week
Plan to share: No
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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Istituto per la Ricerca e l'Innovazione Biomedica