Severe Respiratory Exacerbation
Conditions
Keywords
Severe Respiratory Exacerbation
Brief summary
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.
Interventions
None listed
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severe Respiratory Exacerbation | Baseline hospitalization | 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 |
Countries
Italy