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Clinical Trials in Italy / NCT07666438
Recruiting Observational

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

NCT07666438 · tracked via the Priya Life Science Italy tracker
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Phase
Observational
Started
2026-04-17
Last updated
2026-06-24

Condition(s) studied

Severe Respiratory Exacerbation

Study 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.

Eligibility

Sex
ALL
Min age
30 Days
Max age
7 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
IRCCS Azienda Ospedaliero - Universitaria di Bologna, U.O. Pediatria Bologna Bologna Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07666438 on ClinicalTrials.gov ↗ ← All trials in Italy