Mesenchymal cells for Bronchopulmonary dysplasia

Inclusion criteria

• {"criterion_text":"- Live newborns weighing ≤ 1250 grams and GA ≤ 28 weekswho are on invasive or noninvasive ventilatory support with an FiO2 ≥ 0.3 between days 5 and 14 of life,"}

Exclusion criteria

• {"criterion_text":"- who have other concomitant congenital pathology at the time of inclusion: pulmonary malformations with compromised pulmonary function, active pulmonary hemorrhage, severe pulmonary hypoplasia, renal malformations with systemic compromise, congenital heart disease, polymalformative syndromes, chromosomopathies.\n- who present refractory hemodynamic instability of any cause at the time of inclusion.\n- who present severe neurological injury at the time of inclusion (HIV grade III or higher).\n- Who have required major surgery in the 72 hours prior to inclusion.\n- Who present necrotizing enterocolitis (NEC) grades ≥II at the time of inclusion, according to the Bell classification.\n- who are children of a mother with HIV."}

Primary endpoints

• {"endpoint_text":"- Safety assessment: adverse reactions (AR)","definition_or_measurement_approach":"Assessment of adverse reactions (AR) as safety endpoint (verbatim: \"Safety assessment: adverse reactions (AR)\"). No further measurement method specified in the provided data."}

Secondary endpoints

• {"endpoint_text":"- Status at week 36 EPM (death/DBP grade 3). Diagnosis and stage of BPD at 36 weeks EPM according to Jensen´s classification (no BPD, grade 1, grade 2 or grade 3). Exitus at 36 and 40 weeks of EPM or at discharge (yes/no). Incidence of comorbidities derived from prematurity. Variations in the levels of biomarkers of inflammation, oxidative stress and lung damage with respect to baseline. Variations in the modified respiratory score and RSS score during therapy and up to week 36 EPM.","definition_or_measurement_approach":"Measurements include: classification of BPD at 36 weeks EPM according to Jensen's classification; mortality at 36 and 40 weeks EPM or at discharge (yes/no); incidence of prematurity-related comorbidities; serial measurement of biomarkers of inflammation, oxidative stress and lung damage versus baseline; serial assessment of modified respiratory score and RSS during therapy up to week 36 EPM."}

Spain

Earliest CTIS Part Ii Submission Date

20-09-2024

Latest Decision Or Authorization Date

20-02-2026

Processing Time Days

518

Number Of Sites

9

Number Of Participants

75

Primary sponsor

Full Name

Fundacion Para La Investigacion Biomedica Del Hospital Universitario Ramon Y Cajal

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain

Third parties

• {"country":"","full_name":"Instituto de Salud Carlos III (ICI19/00092).","duties_or_roles":"Source of monetary support","organisation_type":""}