Respiratory Exacerbations in Children With Bronchopulmonary Dysplasia (BPD): A Case-Control Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age30-7
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

800 Participants
are grouped into 2 trial groups
Group A: BPD Group
Group B: Control Group

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline hospitalization

Secondary outcomes

Other outcomes

Sponsors and contacts

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