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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Sicily
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Palermo, Sicily, Italia, 90146
- Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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.
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Electronic nose measurements
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Fraction of Exhaled Nitric Oxide (FeNO)
Periodo de tiempo: 1 week
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1 week
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Pulmonary function (FEV1, FVC, etc.)
Periodo de tiempo: 1 week
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1 week
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 5/2016
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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