Longitudinal Observational Study in Prematurely Born Preschool Children: Assessment of Lung Function Parameters

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Pulmonary function tests will be performed.

Official Title
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Longitudinal Observational Study in Prematurely Born Preschool Children: Assessment of Lung Function Parameters (PRE-AR) (PREMATURELY BORN CHILDREN- ASTHMA AND ALLERGIC RHINITIS )

Conditions
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Asthma, Allergic Rhinitis

Intervention / Treatment
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* Other: Lung Function Assessment


Participation Criteria
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Eligibility Criteria
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Case group Inclusion Criteria: Premature birth < 37 weeks 5 years old ≤ Age ≥ 3 years old Control group Inclusion Criteria: Full-term birth 5 years old ≤ Age ≥ 3 years old Exclusion Criteria of both groups: Pulmonary bronchodysplasia (BDP) Acute respiratory infection Immunological and metabolic system disease Malformation of upper respiratory tract Topical or systemic therapies, with antibiotics, antihistaminics and corticosteroids, in the previous 30 days Patients with neurological pathologies Patients that are not able to perform the lung function tests

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 59 prematurely born children<br>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) | Other: Lung Function Assessment<br>* Lung Function Assessment<br>|
| 93 full-term born children<br>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. | Other: Lung Function Assessment<br>* Lung Function Assessment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Allergic Rhinitis, Children, Atopy