EFFICACY AND SAFETY OF THE INTRATRACHEAL ADMINISTRATION OF BUDESONIDE WITH SURFACTANT TO PREVENT CHRONIC LUNG DISEASE IN PREMATURE BABIES

EFFICACY AND SAFETY OF THE INTRATRACHEAL ADMINISTRATION OF BUDESONIDE WITH SURFACTANT IN VERY PRETERM INFANTS TO PREVENT BRONCHOPULMONARY DYSPLASIA: RANDOMIZED CLINICAL TRIAL

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-005319-33-ES

Enrollment

Registered

2021-03-11

Start date

2021-09-22

Completion date

Unknown

Last updated

2021-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchopulmonary dysplasia of prematurity MedDRA version: 21.1 Level: PT Classification code 10006475 Term: Bronchopulmonary dysplasia System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Trade Name: Budesonida Aldo-Unión 0,50 mg/ml suspensión para inhalación por nebulizador. Pharmaceutical Form: Nebuliser suspension INN or Proposed INN: BUDESONIDE CAS Number: 51333-22-3 Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Infants born earlier than 32 weeks of gestational age admitted in the Neonatal Intensive Care Unit. - Clinical decision to administer intratracheal surfactant. - Parental consent signed. Are the trial subjects under 18? yes Number of subjects for this age range: 70 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Infants with known major congenital anomalies (eg. congenital upper airway obstruction, congenital lung anomaly, severe pulmonary hypoplasia, hydrops, neuromuscular diseases, chromosomopaties) - Infants with poor prognosis and risk of imminent death - Infants who have received the first dose of surfactant before of the enrollment to the study.

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare ecographic (lung ultrasound score) and biological markers (IL-6 concentration in respiratory secretions) of patients who received intratracheal budesonide with surfactant, with those who only received intratracheal surfactant at 7 days of life.;Secondary Objective: 1- To compare the lung ultrasound score of both groups at 28 days of life. 2- To compare IL-6 concentration in respiratory secretions of both groups at 28 days of life. 3- To compare number of days on oxygen and respiratory support of both groups. 4- To compare the incidence of bronchopulmonary dysplasia of both groups. 5- To evaluate possible side effects of the intratracheal administration with surfactant in very preterm infants. 6- To evaluate the respiratory status and neurodevelopment of both groups at 2 years of age.;Primary end point(s): Reduction of the lung ultrasound score by 2 points.;Timepoint(s) of evaluation of this end point: 7 and 28 days of life.	—

Measure

Time frame

Main Objective: To compare ecographic (lung ultrasound score) and biological markers (IL-6 concentration in respiratory secretions) of patients who received intratracheal budesonide with surfactant, with those who only received intratracheal surfactant at 7 days of life.;Secondary Objective: 1- To compare the lung ultrasound score of both groups at 28 days of life. 2- To compare IL-6 concentration in respiratory secretions of both groups at 28 days of life. 3- To compare number of days on oxygen and respiratory support of both groups. 4- To compare the incidence of bronchopulmonary dysplasia of both groups. 5- To evaluate possible side effects of the intratracheal administration with surfactant in very preterm infants. 6- To evaluate the respiratory status and neurodevelopment of both groups at 2 years of age.;Primary end point(s): Reduction of the lung ultrasound score by 2 points.;Timepoint(s) of evaluation of this end point: 7 and 28 days of life.

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Secondary

Measure	Time frame
Secondary end point(s): Reduction of the total days of supplemental oxygen therapy by 5 days.;Timepoint(s) of evaluation of this end point: 28 days of life a nd 36 weeks of corrected gestational age.	—

Countries

Spain

Contacts

Public ContactSecretaría Neonatología

Hospital Clinic BCNatal

003493227 56 007447

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026