Efficacy and safety of the intratracheal administration of budesonide with surfactant in very preterm infants to prevent bronchopulmonary dysplasia: randomized clinical trial.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

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

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16], Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

completed 26 May 2026

Decision date (initial)

2025-01-08

Transition trial

Yes

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-519980-16-00

EudraCT number

2020-005319-33

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety

To evaluate the efficacy of endotracheal administration of budesonide combined with porcine pulmonary surfactant on the incidence of bronchopulmonary dysplasia (BPD) in preterm newborns ≤32 weeks of gestational age. - To evaluate the efficacy of endotracheal administration of the budesonide-porcine pulmonary surfactant mixture by comparing ultrasound markers (lung aeration score) and biological markers of inflammation (IL-6 concentration in nasopharyngeal aspirate) at 7 days of life between patients treated with budesonide and surfactant and those who received only surfactant.
- To evaluate the safety of endotracheal administration of the budesonide-porcine pulmonary surfactant mixture.

Secondary objectives 6

1. To compare the lung aeration score (LAS) at 3, 14, 21, 28 days of life and 36 weeks postmenstrual age (PMA) or prior to discharge between both groups.
2. To compare the IL-6 concentration in nasopharyngeal aspirate at 28 days of life between both groups.
3. To compare the days of oxygen and respiratory support at 28 days of life and 36 weeks PMA or prior to discharge between both groups.
4. To compare the incidence of BPD at 28 days of life and 36 weeks PMA or prior to discharge between both groups.
5. To describe and compare the findings on pulmonary MRI at 36 weeks PMA between both groups.
6. To evaluate the respiratory status and neurodevelopment at two years of corrected age in both groups.

Conditions and MedDRA coding

Bronchopulmonary dysplasia

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 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 2

1. Congenital malformations of the upper airway, hydrops, chromosomal abnormalities, neuromuscular disease, or patients admitted to palliative care.
2. Patients transferred from another center who have received the first dose of endotracheal surfactant at the originating hospital.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Efficacy: Lung ultrasound LAS and IL-6 concentration in nasopharyngeal aspirate on day 7 of life.
2. Safety: Nosocomial sepsis (defined as a positive blood culture in a patient >72 hours of life), gastrointestinal perforation, death (cause and age).

Secondary endpoints 7

1. Lung ultrasound LAS on days 3, 14, 21, and 28 of life and 36 weeks PMA or prior to discharge.
2. IL-6 concentration in nasopharyngeal aspirate on day 28 of life.
3. Days of oxygen and respiratory support at 28 days of life and 36 weeks PMA or prior to discharge.
4. Incidence of BPD at 28 days and 36 weeks PMA or prior to discharge.
5. Adverse effects of budesonide.
6. 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.
7. 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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

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

Sponsor organisation

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

Address

Calle Rosellon 149-153

City

Barcelona

Postcode

08036

Country

Spain

Scientific contact point

Organisation

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

Contact name

Marta Teresa

Public contact point

Organisation

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

Contact name

Marta Teresa

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications