About this trial
This is an ambispective observational case-control study evaluating respiratory exacerbations in pediatric patients affected by bronchopulmonary dysplasia (BPD) compared with children without BPD. The study includes a retrospective cohort (January 2020 to September 2025) and a prospective cohort (from study approval to December 2030). Patients admitted to the Pediatric Emergency Department or Pediatric Unit for lower respiratory tract infections will be consecutively enrolled and managed according to standard clinical practice.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Corrected age ≥30 days and ≤7 years Acute lower respiratory tract infection
Disqualifiers
Grade ≥3 intraventricular hemorrhage Major congenital heart disease Neuromuscular disorders Chromosomal/genetic syndromes Primary pulmonary diseases Major skeletal dysplasia
Trial population
Children with bronchopulmonary dysplasia and respiratory exacerbation, and Children without bronchopulmonary dysplasia admitted for respiratory exacerbation.
Trial design
Case-control
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Severe Respiratory Exacerbation
Occurrence of severe respiratory exacerbation defined as at least one of the following: need for non-invasive respiratory support (CPAP/NIV) for ≥24 hours admission to pediatric intensive care unit hospitalization lasting ≥5 days
Sponsors and contacts
Click on the lead sponsor to view all of their trials.