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Covid-2019
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The PRE-AR project is a longitudinal observational study. The primary objective is the assessment of lung function parameters in late preterm preschool children.
The PRE-AR project is a longitudinal observational study. The primary objective is the assessment of lung function parameters in late preterm preschool children.
Pulmonary function tests will be performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 59 prematurely born children | Lung function assessment of 59 prematurely born children (of both sex and 3-5 years old) attending as outpatient clinic of Pediatric Allergology & Pulmonology (PAP) of Respiratory Disease Research Center (RDRC) within the Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (RDRC-IBIM CNR) |
| |
| 93 full-term born children | Lung function assessment of a Control group of full-term born children (N=93), recruited by a collaborative Pediatricians network within the Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (RDRC-IBIM CNR), Italy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lung Function Assessment | Other | Lung Function Assessment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Forced oscillation technique | Longitudinal assessment of forced oscillation technique (FOT) | Baseline, 24 months, and 48 months |
| Spirometry | Longitudinal assessment of spirometry | Baseline, 24 months, and 48 months |
| Interrupter resistance | Longitudinal assessment of interrupter resistance (RINT) | Baseline, 24 months, and 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| Nasal nitric oxide | Longitudinal assessment of nasal nitric oxide (nNO) | Baseline, 24 months, and 48 months |
| Atopy | Positivity to at least one aeroallergen |
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Case group
Inclusion Criteria:
Control group
Inclusion Criteria:
Exclusion Criteria of both groups:
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A study population of 59 prematurely born children (of both sex and 3-5 years old) attending as outpatient clinic of Pediatric Allergology & Pulmonology (PAP) of Respiratory Disease Research Center (RDRC) within the Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (RDRC-IBIM CNR).
A Control group of full-term born children (N=93), recruited by a collaborative Pediatricians network within the Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (RDRC-IBIM CNR), Italy.
The subjects will be paired up according to the sex and to the age, with a ratio 1:1.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Biomedicine and Molecular Immunology, IBIM | Palermo | Palermo | 90146 | Italy |
The IPD collected will be available on december 2023.
The following participant data will be shared:
All IPD will be obtained from statistical analysis on the dedicated database in which all data are stored.
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Baseline |
| Nasal brushing | Assessment of alterations and inflammatory changes in the nasal mucosa | Baseline |
| Saliva sample | Phenotypic characterization through the collection of saliva samples | 24 months, and 48 months |
| Urine analysis | Endotypic characterization through urine proteomic analysis | Baseline, 24 months, and 48 months |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D010038 | Otorhinolaryngologic Diseases |