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

Overview

The PRE-AR project is a longitudinal observational study. The primary objective is the assessment of lung function parameters in late preterm preschool children.

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2022

Detailed Description

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.

Interventions

  • Other: Lung Function Assessment
    • Lung Function Assessment

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Forced oscillation technique
    • Time Frame: Baseline, 24 months, and 48 months
    • Longitudinal assessment of forced oscillation technique (FOT)
  • Spirometry
    • Time Frame: Baseline, 24 months, and 48 months
    • Longitudinal assessment of spirometry
  • Interrupter resistance
    • Time Frame: Baseline, 24 months, and 48 months
    • Longitudinal assessment of interrupter resistance (RINT)

Secondary Measures

  • Nasal nitric oxide
    • Time Frame: Baseline, 24 months, and 48 months
    • Longitudinal assessment of nasal nitric oxide (nNO)
  • Atopy
    • Time Frame: Baseline
    • Positivity to at least one aeroallergen
  • Nasal brushing
    • Time Frame: Baseline
    • Assessment of alterations and inflammatory changes in the nasal mucosa
  • Saliva sample
    • Time Frame: 24 months, and 48 months
    • Phenotypic characterization through the collection of saliva samples
  • Urine analysis
    • Time Frame: Baseline, 24 months, and 48 months
    • Endotypic characterization through urine proteomic analysis

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 3 Years

Maximum Age: 5 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Stefania La Grutta, MD
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Stefania La Grutta, MD, Stefania La Grutta, MD. Senior Researcher. Coordinator of Pediatric Allergy and Asthma Research Group. Institute of Biomedicine and Molecular Immunology, IBIM, National Research Council of Palermo, Italy. – Istituto per la Ricerca e l’Innovazione Biomedica

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