Infants will be followed up to 2 years of corrected age (end of study). conditions: Bronchopulmonary Dysplasia studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Phase 1 is an open-labelled, dose-escalated, and single-arm of EXOB-001. Phase 2 is a randomised, double-blind, placebo-controlled, and dose-finding of EXOB-001. primaryPurpose: PREVENTION masking: DOUBLE maskingDescription: Phase 1 is an open-label, dose-escalation and single-arm study. In phase 2, Investigators will remain blinded to each subject's assigned treatment throughout the study. The Sponsor will put in place procedures to maintain this blind. Indeed, to ensure the blinding of the groups, the preparation and administration of the test product will be organized by different teams. In the event of a Quality Assurance audit, the auditor(s) will be allowed access to unblinded study treatment records at the site(s) to verify that randomisation/dispensing has been done accurately. Blinding will be broken by the Investigator for emergency purposes only, where knowledge of the blinded treatment could influence further subject care. In addition, subjects will be unblinded for safety reports, as per regulatory requirements. Study blind will be broken after the database lock. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 265 type: ESTIMATED name: Endotracheopulmonary Instillation, Suspension measure: Number of subjects with treatment-emergent adverse events (phase 1) measure: Number of subjects with BPD grade II-III incidence rate per groups (phase 2). measure: Assessment of medium-term safety of EXOB-001 (phase 1/2) measure: Number of subjects with dose-limiting toxicity (DLT) (phase 1) measure: Number of subjects needing for oxygen and ventilation for BPD incidence (phase 1/2) measure: Assessment of immune markers (phase 2) measure: Assessment of BPD incidence and severity (phase 1/2) measure: Safety evaluation (phase 1/2) measure: Assessment of lung ultrasound score (phase 1/2) measure: Number of subjects with complications of prematurity (phase 1/2) measure: Assessment of the respiratory morbidity (phase 1/2) measure: Assessment of neurodevelopment (phase 1/2) sex: ALL maximumAge: 10 Days stdAges: CHILD facility: Cliniques Universitaires Saint-Luc (UCLouvain) status: NOT_YET_RECRUITING city: Brussels zip: 1200 country: Belgium name: Olivier Danhaive, M.D. role: CONTACT phone: +32 2 764 79 00 email: olivier.danhaive@saintluc.uclouvain.be name: Olivier Danhaive, M.D. role: PRINCIPAL_INVESTIGATOR lat: 50.85045 lon: 4.34878 facility: ISPPC CHU Charleroi status: NOT_YET_RECRUITING city: Charleroi zip: 6000 country: Belgium name: Serge Vanden Eijnden, M.D. role: CONTACT phone: +32 7 192 12 43 email: serge.vandeneijnden@chu-charleroi.be name: Serge Vanden Eijnden, M.D. role: PRINCIPAL_INVESTIGATOR lat: 50.41136 lon: 4.44448 facility: Clinique CHC Montlégia status: NOT_YET_RECRUITING city: Liège zip: 4000 country: Belgium name: Pierre Maton, M.D. role: CONTACT phone: +32 4 355 56 17 email: pierre.maton@chc.be name: Pierre Maton, M.D. role: PRINCIPAL_INVESTIGATOR lat: 50.63373 lon: 5.56749 facility: AOU Careggi status: NOT_YET_RECRUITING city: Florence country: Italy name: Carlo Dani, M.D. role: CONTACT phone: +39 055 7948421 email: carlo.dani@unifi.it name: Carlo Dani, M.D. role: PRINCIPAL_INVESTIGATOR lat: 43.77925 lon: 11.24626 facility: IRCCS Instituto Giannina Gaslini status: NOT_YET_RECRUITING city: Genova country: Italy name: Giorgia Brigati, M.D. role: CONTACT phone: +39 010 56362218 email: giorgiabrigati@gaslini.org name: Giorgia Brigati, M.D. role: PRINCIPAL_INVESTIGATOR lat: 44.40478 lon: 8.94438 facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico status: NOT_YET_RECRUITING city: Milan country: Italy name: Anna Lavizzari, M.D. role: CONTACT email: anna.lavizzari@policlinico.mi.it role: CONTACT phone: +39 025 5032907 name: Anna Lavizzari, M.D. role: PRINCIPAL_INVESTIGATOR lat: 45.46427 lon: 9.18951 facility: AOU Policlinico di Modena status: NOT_YET_RECRUITING city: Modena country: Italy name: Alberto Berardi, M.D. role: CONTACT phone: +39 333 1053301 email: alberto.berardi@unimore.it name: Alberto Berardi, M.D. role: PRINCIPAL_INVESTIGATOR lat: 44.64783 lon: 10.92539 facility: Unità di Fase I della UOC Terapia Intensiva e Patologia Neonatale, Assistenza Neonatale (TINI) dell'Azienda Ospedale Università di Padova status: RECRUITING city: Padua zip: 35128 country: Italy name: Eugenio Baraldi, Prof role: CONTACT phone: +39 049 8213578 email: eugenio.baraldi@unipd.it name: Eugenio Baraldi, Prof role: PRINCIPAL_INVESTIGATOR lat: 45.40797 lon: 11.88586 hasResults: False