Clinical trial Recruiting at 1 site Observational Ages 30 Days to 7

Respiratory Exacerbations in Children With BPD: A Case-Control Look at Severe Infections

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

Run by IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT07666438 · Data updated 2026-11-12

This study tests how often severe respiratory infections happen in children with bronchopulmonary dysplasia compared with similar kids without BPD.

Quick facts

Study typeObservational
Ages30 Days to 7 Years
SexAll
Enrollment800 (estimated)
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna
Academic / other
Locations1 site (Bologna, Bologna)
StatusRecruiting
StartedApril 17, 2026
Main results expectedDecember 31, 2030
Study endsDecember 31, 2030
Registry record updatedJune 24, 2026
Trial IDNCT07666438 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Children aged 30 days to 7 years with an acute lower respiratory infection, and at least one criterion of respiratory distress, with or without diagnosed BPD.

Probably not a fit

Children without broncpulmonary dysplasia or those without acute lower respiratory infections may not benefit from the study insights.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an ambispective observational case-control study comparing pediatric patients with bronchopulmonary dysplasia (BPD) to those without BPD who are admitted for lower respiratory tract infections. It includes a retrospective cohort from January 2020 to September 2025 and a prospective cohort from approval through December 2030. Consecutive participants are enrolled from the Pediatric Emergency Department or Pediatric Unit and managed according to standard clinical practice. The study aims to identify differences in respiratory exacerbations and related clinical features between the two groups. Interventions are not specified as this is an observational design.

Why it matters

Potential benefit: Findings could clarify risk factors and patterns of severe respiratory exacerbations in children with BPD, informing better management strategies.

How similar studies have gone: Observational studies in similar populations have identified distinct patterns of respiratory exacerbations in BPD, supporting feasibility of this approach.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

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

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.