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

NCT02636933 | Terminated

• 1 other identifier: 9/2014
• Study Type: observational
• Target: 152
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Allergic Rhinitis

Keywords

Asthma; Allergic Rhinitis; Children; Atopy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Nasal nitric oxide

  Baseline, 24 months, and 48 months

• Atopy

  Baseline

• Nasal brushing

  Baseline

• Saliva sample

  24 months, and 48 months

• Urine analysis

  Baseline, 24 months, and 48 months

Study Arms (2)

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)

Other: Lung Function Assessment

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.

Other: Lung Function Assessment

Interventions

Lung Function Assessment OTHER

Lung Function Assessment

59 prematurely born children; 93 full-term born children

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Premature birth \< 37 weeks
• years old ≤ Age ≥ 3 years old
• Control group
• Full-term birth
• years old ≤ Age ≥ 3 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Stefania La Grutta, MD: lead

Study Sites (1)

Institute of Biomedicine and Molecular Immunology, IBIM

Palermo, Palermo, 90146, Italy

Location

MeSH Terms

Conditions

Asthma; Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Rhinitis; Nose Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: 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.

Study Record Dates

• First Submitted: October 2, 2015
• First Posted: December 22, 2015
• Study Start: March 1, 2015
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)