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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Asthma; Allergic Rhinitis
• Intervention / Treatment: Other: Lung Function Assessment

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 Type: Observational
• Enrollment (Actual): 152

Contacts and Locations

Study Locations

• Italy
  • Palermo, Italy, 90146
    • Institute of Biomedicine and Molecular Immunology, IBIM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 5 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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; Lung Function Assessment

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Stefania La Grutta, MD

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: October 2, 2015
• First Submitted That Met QC Criteria: December 18, 2015
• First Posted (ESTIMATE): December 22, 2015

Study Record Updates

• Last Update Posted (ACTUAL): August 3, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Asthma; Children; Allergic Rhinitis; Atopy
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Otorhinolaryngologic Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Asthma; Rhinitis; Rhinitis, Allergic
• Other Study ID Numbers: 9/2014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

The IPD collected will be available on december 2020.

The following participant data will be shared:

• Pulmonary function tests
• Demographic characteristics

All IPD will be obtained from statistical analysis on the dedicated database in which all data are stored.