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

NCT07666438 | Recruiting DMC

• 1 other identifier: BPD-CC25
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Respiratory Exacerbation

Keywords

Severe Respiratory Exacerbation

Outcome Measures

Primary Outcomes (1)

• Severe Respiratory Exacerbation

  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

  Baseline hospitalization

Study Arms (2)

BPD Group

Children with bronchopulmonary dysplasia and respiratory exacerbation.

Control Group

Children without bronchopulmonary dysplasia admitted for respiratory exacerbation

Eligibility Criteria

• Age: 30 Days - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children with bronchopulmonary dysplasia and respiratory exacerbation, and Children without bronchopulmonary dysplasia admitted for respiratory exacerbation.

You may qualify if:

• 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

You may not qualify if:

• Grade ≥3 intraventricular hemorrhage Major congenital heart disease Neuromuscular disorders Chromosomal/genetic syndromes Primary pulmonary diseases Major skeletal dysplasia

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

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

Bologna, Bologna, 40138, Italy

RECRUITING

Central Study Contacts

Marianna Fabi, MD

CONTACT

+390512143012; marianna.fabi@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2026
• First Posted: June 24, 2026
• Study Start: April 17, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: June 24, 2026

Record last verified: 2026-06

Locations

IT (1)