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 )

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02636933

Enrollment

152

Registered

2015-12-22

Start date

2015-03-01

Completion date

2020-02-01

Last updated

2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Rhinitis, Asthma

Keywords

Asthma, Allergic Rhinitis, Children, Atopy

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.

Interventions

OTHERLung Function Assessment

Lung Function Assessment

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

3 Years to 5 Years

Healthy volunteers

Inclusion 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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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
Saliva sample	24 months, and 48 months	Phenotypic characterization through the collection of saliva samples
Urine analysis	Baseline, 24 months, and 48 months	Endotypic characterization through urine proteomic analysis

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 15, 2026