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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07666438
Acronym
BPD-CC25
Enrollment
800
Registered
2026-06-24
Start date
2026-04-17
Completion date
2030-12-31
Last updated
2026-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Respiratory Exacerbation

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

IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
30 Days to 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

Design outcomes

Primary

MeasureTime frameDescription
Severe Respiratory ExacerbationBaseline hospitalizationOccurrence 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

Contacts

CONTACTMarianna Fabi, MD
marianna.fabi@aosp.bo.it+390512143012

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 25, 2026