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 range

3 Years – 5 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Asthma trials

Who can participate

Age range

3 Years – 5 Years

Sex

ALL

See this in plain English?

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