Understanding the development of broncho-pulmonary dysplasia (BPD) in preterm infants: mechanisms and different forms of BPD
| ISRCTN | ISRCTN12233815 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12233815 |
- Submission date
- 16/08/2025
- Registration date
- 19/08/2025
- Last edited
- 19/08/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
Some babies born very early (prematurely) can develop a serious lung condition called broncho-pulmonary dysplasia (BPD). This condition can affect their growth, brain development, and heart and lung health later in life. Doctors and researchers believe there may be different types of BPD, each developing in its own way, but we don’t yet fully understand how or why. This study aims to learn more about the different forms of BPD and how they develop, which could help improve care for these babies in the future.
Who can participate?
Any newborn baby born before 30 weeks of pregnancy (gestational age) can take part in the study.
What does the study involve?
The study does not involve any extra tests or procedures. It simply uses information that is already being collected as part of the baby’s normal hospital care. This includes things like data from breathing support machines, vital signs monitoring, and routine lung scans.
What are the possible benefits and risks of participating?
There are no risks to taking part in the study because nothing about the baby’s care will change. The information collected could help doctors better understand BPD and eventually lead to more personalised treatments for babies with different types of the condition.
Where is the study run from?
The study is being carried out in several specialist newborn intensive care units and research centres across Europe.
When is the study starting and how long is it expected to run for?
The study is already underway and is expected to continue until sometime in 2026, depending on how many babies are enrolled.
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Almudena Alonso-Ojembarrena, almudena.alonso.sspa@juntadeandalucia.es
Contact information
Public, Scientific, Principal Investigator
Av. Ana de Viya, 21
Cadiz
11009
Spain
| Phone | +34956 002 700 |
|---|---|
| almudena.alonso.sspa@juntadeandalucia.es |
Study information
| Study design | Observational prospective multi-center non-invasive pragmatic study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital, University/medical school/dental school |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Pathophysiology phenotypes in infants developing BPD |
| Study acronym | PATH-BPD |
| Study objectives | Clarifying pathophysiology and biology phenotypes of BPD |
| Ethics approval(s) |
Approved 05/07/2023, Junta de Andalucia - Comité ed Ética ed al Investigación de Cádiz (Avenida Ana deViva, 12- 11009 Cadiz, Cadiz, 11009, Spain; +34 950002100; ceic.hpm.sspa@juntadeandalucia.es), ref: TFG-LUSNEO1-2023 |
| Health condition(s) or problem(s) studied | Broncho-pulmonary dysplasia |
| Intervention | Analysis of clinical, imaging physiological and vital data routinely collected during NICU care. |
| Intervention type | Other |
| Primary outcome measure | Gas exchange metrics, lung aeration, vital functions, respiratory support and lung mechanics data are registered at 10, 21 and 28 days of life as well as at 34 and 36 weeks post-conceptional age. Measurements are performed with commonly used techniques such as transcutaneous blood gas monitoring, blood gas analyses, quantitative lung ultrasound, electrical cardiometry, pulsoxymetry and the measurements shown by mechanical ventilators screens, as per clinical routine |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/12/2023 |
| Completion date | 31/12/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | A convenience sample size of approximately 300 participants is expected to be enrolled. However, since this is the first study on pathophysiological phenotypes of BPD, a formal sample size calculation is unfeasible |
| Key inclusion criteria | Preterm neonates (GA <=30 weeks) |
| Key exclusion criteria | 1. Complex malformations or chromosomal abnormalities 2. Congenital lung anomalies 3. Pneumothorax, pneumomediastinum or pleural effusion 4. Need for surgery 5. Severe hemodynamic instability (defined as any need for inotropes) at any time during the study |
| Date of first enrolment | 01/01/2024 |
| Date of final enrolment | 31/12/2026 |
Locations
Countries of recruitment
- France
- Italy
- Spain
Study participating centres
Cadiz
11009
Spain
Clamart
92140
France
Padova
35128
Italy
Sponsor information
Hospital/treatment centre
Av. Ana de Viya, 21, 11009 Cádiz, Spagna
Cadiz
11009
Spain
| Phone | +34 956 00 21 00 |
|---|---|
| simonp.lubian.sspa@juntadeandalucia.es | |
| Website | http://hospitalpuertadelmar.com/ |
"ROR" |
https://ror.org/040xzg562 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Study results will be diffused via one or several articles representing subsection of the study published in major international journals in the field of "critical care" or "pediatrics". Partial results will also be presented at the main conferences in the field (such as PAS, ATS or ESPNIC) |
| IPD sharing plan | The anonymised datasets generated and analysed will be available upon adequate request from researchers, respecting all relevant regulations. They will need to be requested to the main study contact (see above) and the establishment of a CDA may be needed. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Statistical Analysis Plan | 19/08/2025 | No | No |
Additional files
Editorial Notes
18/08/2025: Trial's existence confirmed by JUNTA DE ANDALUCIA.
