BUDESONIDE for Bronchopulmonary dysplasia | Preterm birth (very preterm, ≤32 weeks gestational age)

Inclusion criteria

• {"criterion_text":"- All preterm newborns ≤32 weeks of gestational age, regardless of their birth weight, who are admitted to the Neonatal Unit, and whose parents/legal representative have signed the informed consent."}

Exclusion criteria

• {"criterion_text":"- Congenital malformations of the upper airway, hydrops, chromosomal abnormalities, neuromuscular disease, or patients admitted to palliative care."}
• {"criterion_text":"- Patients transferred from another center who have received the first dose of endotracheal surfactant at the originating hospital."}

Primary endpoints

• {"endpoint_text":"- Efficacy: Lung ultrasound LAS and IL-6 concentration in nasopharyngeal aspirate on day 7 of life.","definition_or_measurement_approach":"Lung ultrasound LAS (lung aeration score) measured by lung ultrasound; IL-6 concentration measured in nasopharyngeal aspirate on day 7 of life."}
• {"endpoint_text":"- Safety: Nosocomial sepsis (defined as a positive blood culture in a patient >72 hours of life), gastrointestinal perforation, death (cause and age).","definition_or_measurement_approach":"Nosocomial sepsis defined as positive blood culture in a patient >72 hours of life; gastrointestinal perforation and death recorded with cause and age."}

Secondary endpoints

• {"endpoint_text":"- Lung ultrasound LAS on days 3, 14, 21, and 28 of life and 36 weeks PMA or prior to discharge.","definition_or_measurement_approach":"Lung aeration score (LAS) by lung ultrasound at specified days and at 36 weeks postmenstrual age or prior to discharge."}
• {"endpoint_text":"- IL-6 concentration in nasopharyngeal aspirate on day 28 of life.","definition_or_measurement_approach":"IL-6 concentration measured in nasopharyngeal aspirate on day 28 of life."}
• {"endpoint_text":"- Days of oxygen and respiratory support at 28 days of life and 36 weeks PMA or prior to discharge.","definition_or_measurement_approach":"Number of days on supplemental oxygen and respiratory support recorded at 28 days and at 36 weeks PMA or prior to discharge."}
• {"endpoint_text":"- Incidence of BPD at 28 days and 36 weeks PMA or prior to discharge.","definition_or_measurement_approach":"Incidence of bronchopulmonary dysplasia assessed at 28 days and at 36 weeks postmenstrual age or prior to discharge."}
• {"endpoint_text":"- Adverse effects of budesonide.","definition_or_measurement_approach":"Recording and characterization of adverse events related to budesonide administration."}
• {"endpoint_text":"- Neurodevelopmental assessment at 2 years of life: using the Bayley III test, which evaluates cognitive, visual, fine and gross motor skills, memory, receptive and expressive language, and processing speed.","definition_or_measurement_approach":"Bayley III test administered at 2 years corrected age assessing multiple neurodevelopmental domains (cognitive, visual, motor, memory, language, processing speed)."}
• {"endpoint_text":"- Evaluation of respiratory outcomes at 2 years of life: Need and duration of home oxygen therapy, maintenance corticosteroid or bronchodilator treatment, diagnosis of pulmonary hypertension, number of hospital admissions due to respiratory causes, and details of the underlying cause.","definition_or_measurement_approach":"Clinical assessment and medical record review at 2 years corrected age to record home oxygen need/duration, maintenance respiratory medications, pulmonary hypertension diagnosis, hospital admissions for respiratory causes and underlying causes."}

Spain

Earliest CTIS Part Ii Submission Date

18-12-2024

Latest Decision Or Authorization Date

08-01-2025

Processing Time Days

21

Number Of Sites

2

Number Of Participants

60

Primary sponsor

Full Name

Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain