Clinical trial NCT02636933: Longitudinal Observational Study in Prematurely Born Preschool Children: Assessment of Lung Function Parameters
Official title: Longitudinal Observational Study in Prematurely Born Preschool Children: Assessment of Lung Function Parameters (PRE-AR) (PREMATURELY BORN CHILDREN- ASTHMA AND ALLERGIC RHINITIS )
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asthma
Allergic Rhinitis
Keywords: Asthma
Allergic Rhinitis
Children
Atopy
Lead sponsor: Istituto per la Ricerca e l'Innovazione Biomedica
Sponsor class: OTHER
First posted: 2015-12-22
Enrollment: 152
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: Forced oscillation technique
timeFrame: Baseline, 24 months, and 48 months
measure: Spirometry
timeFrame: Baseline, 24 months, and 48 months
measure: Interrupter resistance
timeFrame: Baseline, 24 months, and 48 months
Secondary outcomes:
measure: Nasal nitric oxide
timeFrame: Baseline, 24 months, and 48 months
measure: Atopy
timeFrame: Baseline
measure: Nasal brushing
timeFrame: Baseline
measure: Saliva sample
timeFrame: 24 months, and 48 months
measure: Urine analysis
timeFrame: Baseline, 24 months, and 48 months
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: Institute of Biomedicine and Molecular Immunology, IBIM
Study officials:
References: