Severe Respiratory ExacerbationBPD-CC25NCT07666438
Respiratory Exacerbations in Children With Bronchopulmonary Dysplasia (BPD): A Case-Control Study
An observational study of Severe Respiratory Exacerbation, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 days to 7 years
- Conditions the study is for
- Severe Respiratory Exacerbation
- How many people
- 800 participants
- Where
- 1 siteItaly
- Study dates
- 17 Apr 2026to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 days to 7 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with bronchopulmonary dysplasia and respiratory exacerbation, and Children without bronchopulmonary dysplasia admitted for respiratory exacerbation.
Who may be able to join
- 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
Who cannot join
- Grade ≥3 intraventricular hemorrhage Major congenital heart disease Neuromuscular disorders Chromosomal/genetic syndromes Primary pulmonary diseases Major skeletal dysplasia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero - Universitaria di Bologna, U.O. Pediatria
Bologna, Bologna, 40138
Marianna Fabi, MD, 0512143012, marianna.fabi@aosp.bo.it
About this study
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| BPD Group | Children with bronchopulmonary dysplasia and respiratory exacerbation. | |
| Control Group | Children without bronchopulmonary dysplasia admitted for respiratory exacerbation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start17 Apr 2026
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Respiratory ExacerbationStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07666438
- Sponsor's protocol ID
- BPD-CC25
- Acronym
- BPD-CC25
- Status last verified
- Jun 2026
- First submitted
- 19 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Exacerbations in Children With Bronchopulmonary Dysplasia (BPD): A Case-Control Study
- ClinicalTrials.gov ID
- NCT07666438
- Acronym / sponsor ID
- BPD-CC25 / BPD-CC25
- Conditions
- Severe Respiratory Exacerbation
- Keywords
- Severe Respiratory Exacerbation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 17 Apr 2026 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BPD Group | – | –Children with bronchopulmonary dysplasia and respiratory exacerbation. |
| Control Group | – | –Children without bronchopulmonary dysplasia admitted for respiratory exacerbation |
Who may qualify
- Ages
- 30 days to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with bronchopulmonary dysplasia and respiratory exacerbation, and Children without bronchopulmonary dysplasia admitted for respiratory exacerbation.
Key inclusion criteria (3 listed)
- Corrected age ≥30 days and ≤7 years Acute lower respiratory tract infection
- tachypnea for age SpO2 <94% increased work of breathing Gestational age <32 weeks Diagnosis of bronchopulmonary dysplasia according to NICHD 2018 definition
Key exclusion criteria (1 listed)
- Grade ≥3 intraventricular hemorrhage Major congenital heart disease Neuromuscular disorders Chromosomal/genetic syndromes Primary pulmonary diseases Major skeletal dysplasia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Severe Respiratory Exacerbation
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Respiratory Exacerbation, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marianna Fabi, MD (+390512143012, marianna.fabi@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe Respiratory Exacerbation (time frame: Baseline hospitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.