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

Stefania La Grutta, MD

Status: Active, not recruiting

Conditions: Asthma; Allergic Rhinitis

Treatments: Other: Lung Function Assessment

Study type: Observational

Funder types: Other

Identifiers

NCT02636933

9/2014

Details and patient eligibility

About

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 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.

Enrollment: 152 patients

Sex: All

Ages: 3 to 5 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

152 participants in 2 patient groups

59 prematurely born children

Description:

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)

Treatment:

Other: Lung Function Assessment

93 full-term born children

Description:

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.

Treatment:

Other: Lung Function Assessment