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

Phase 1

• Conditions: High risk of bronchopulmonary dysplasia in very preterm neonates; MedDRA version: 12.1Level: LLTClassification code 10006475Term: Bronchopulmonary dysplasia

• Registration Number: EUCTR2009-012203-26-EE
• Lead Sponsor: niversitätsklinikum Tübingen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-04-26
• Study Completion: 2016-07-31
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 863

Inclusion Criteria

Entry criteria involve a gestational age of 23 0/7- 27 6/7 weeks, a postnatal age < 12 hours, the necessity for any form of positive pressure support (mechanical or nasal ventilation or CPAP), singleton or second born in case of multiple pregnancy and parental consent for participation.
Are the trial subjects under 18? yes
Number of subjects for this age range:
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 involve 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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified