NCT07666438 Respiratory Exacerbations in Children With Bronchopulmonary Dysplasia (BPD): A Case-Control Study
| NCT ID | NCT07666438 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
| Condition | Severe Respiratory Exacerbation |
| Study Type | OBSERVATIONAL |
| Enrollment | 800 participants |
| Start Date | 2026-04-17 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 800 participants in total. It began in 2026-04-17 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07666438 clinical trial?
This trial is open to participants of all sexes, aged 30 Days or older, up to 7 Years, studying Severe Respiratory Exacerbation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07666438 currently recruiting?
Yes, NCT07666438 is actively recruiting participants. Contact the research team at marianna.fabi@aosp.bo.it for enrollment information.
Where is the NCT07666438 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT07666438 clinical trial?
NCT07666438 is sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. The trial plans to enroll 800 participants.