Efficacy and Safety of Inhaled Budesonide in Very Preterm Infants at Risk for Bronchopulmonary Dysplasia - NEUROSIS

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-012203-26-DE

Enrollment

850

Registered

2009-06-22

Start date

2009-11-19

Completion date

Unknown

Last updated

2016-08-08

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

Conditions

Survival of Extremely Low Birth Weight (ELBW) infants has improved in recent decades but Bronchopulmonary Dysplasia (BPD) remains a major health care problem. BPD is a chronic lung disease that occurs in premature infants requiring mechanical ventilation and oxygen therapy, but also develops in preterm neonates who require little or no ventilatory or oxygen support. MedDRA version: 14.1 Level: PT Classification code 10006475 Term: Bronchopulmonary dysplasia System Organ Class: 10038738 - Respi

Interventions

Trade Name: Budiair Pharmaceutical Form: Pressurised inhalation, solution Pharmaceutical form of the placebo: Inhalation vapour, solution Route of administration of the placebo: Inhalation use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: A gestational age of 23 0/7-27 6/7 weeks,a postnatal age =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: A clinical decision not to administer therapies (infant not considered viable), dysmorphic features or congenital malformations that adversely affect life expectancy or neurodevelopment and known or suspected congenital heart disease (not including a persistent ductus arteriosus and/or an atrial septum defect). The clinical assessment of dysmorphic features, congenital malformations, suspected congenital heart disease and the decision to exlude an infant for the afore mentioned reasons will be left to the discretion of the attending physician.

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine if the early (within 12 hours of life) prophylactic use of inhaled corticosteroids (Budesonide) in very preterm infants (gestational age 23 0/7-27 6/7 weeks) requiring any form of positive pressure support (mechanical or nasal ventilation or continuous positive airway pressure (CPAP)) increases survival without bronchopulmonary dysplasia (BPD) at 36 weeks gestational age.;Secondary Objective: To determine whether early inhalation of corticosteroids for the prevention of BPD alters the incidence of infants born prematurely with neurodevelopmental impairment at a corrected age of 18 to 22 months. To determine whether inhalation of corticosteroids is associated with adverse treatment effects, alters mortality at 36 weeks gestational age, BPD incidence at 36 weeks gestational age, and the duration of positive pressure respiratory support or supplemental oxygen. ;Primary end point(s): The parameter for the confirmatory analysis of efficacy will be the incidence of primary endpoints. A primary endpoint is defined as the occurrence of any of the following events during the first 36 weeks gestational age: (1) Death for any reason until the end of week 36 gestational age; (2) BPD according to the physiological definition, diagnosed at 36 weeks +/- 1 day gestational age.	—

Measure

Time frame

Main Objective: To determine if the early (within 12 hours of life) prophylactic use of inhaled corticosteroids (Budesonide) in very preterm infants (gestational age 23 0/7-27 6/7 weeks) requiring any form of positive pressure support (mechanical or nasal ventilation or continuous positive airway pressure (CPAP)) increases survival without bronchopulmonary dysplasia (BPD) at 36 weeks gestational age.;Secondary Objective: To determine whether early inhalation of corticosteroids for the prevention of BPD alters the incidence of infants born prematurely with neurodevelopmental impairment at a corrected age of 18 to 22 months. To determine whether inhalation of corticosteroids is associated with adverse treatment effects, alters mortality at 36 weeks gestational age, BPD incidence at 36 weeks gestational age, and the duration of positive pressure respiratory support or supplemental oxygen. ;Primary end point(s): The parameter for the confirmatory analysis of efficacy will be the incidence of primary endpoints. A primary endpoint is defined as the occurrence of any of the following events during the first 36 weeks gestational age: (1) Death for any reason until the end of week 36 gestational age; (2) BPD according to the physiological definition, diagnosed at 36 weeks +/- 1 day gestational age.

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Countries

Belgium, Estonia, Finland, France, Germany, Greece, Netherlands

Outcome results

None listed

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