TerminatedNot Applicable

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

Stopped: Covid-2019

Italy152 participantsStarted 2015-03

Plain-language 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.

Who can participate

Age range3 Years – 5 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Forced oscillation technique

Timeframe: Baseline, 24 months, and 48 months

Spirometry

Timeframe: Baseline, 24 months, and 48 months

Interrupter resistance

Timeframe: Baseline, 24 months, and 48 months

Trial details

NCT IDNCT02636933

SponsorStefania La Grutta, MD

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-02

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