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

• Conditions: Allergic Rhinitis; Asthma
• Interventions: Other: Lung Function Assessment

• Registration Number: NCT02636933
• Lead Sponsor: Stefania La Grutta, MD

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-10-02
• Study First Submitted QC: 2015-12-18
• Study First Posted: 2015-12-22
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-02
• Last Update Posted: 2022-08-03
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 152

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
59 prematurely born children	Lung Function Assessment	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	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Institute of Biomedicine and Molecular Immunology, IBIM; 🇮🇹 Palermo, Italy