Menu
Recruiting NCT07666438

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

Observational Severe Respiratory Exacerbation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Severe Respiratory Exacerbation. Basic parameters: 30 Days — 7 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Severe Respiratory Exacerbation [Time frame: Baseline hospitalization]

Eligibility criteria

Inclusion criteria

  • Corrected age ≥30 days and ≤7 years Acute lower respiratory tract infection

At least one of:

tachypnea for age SpO2 <94% increased work of breathing Gestational age <32 weeks Diagnosis of bronchopulmonary dysplasia according to NICHD 2018 definition

Exclusion criteria

  • Grade ≥3 intraventricular hemorrhage Major congenital heart disease Neuromuscular disorders Chromosomal/genetic syndromes Primary pulmonary diseases Major skeletal dysplasia

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

Italy · 1 center
  • IRCCS Azienda Ospedaliero - Universitaria di Bologna, U.O. Pediatria — Bologna

Identifiers

NCT: NCT07666438 · BPD-CC25

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗