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

Phase 1

• 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: 14.1Level: PTClassification code 10006475Term: Bronchopulmonary dysplasiaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2009-012203-26-BE
• Lead Sponsor: niversity Children’s Hospital, Department of Neonatology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-01
• Last Update Posted: 8 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 850

Inclusion Criteria

A gestational age of 23 0/7-27 6/7 weeks, a postnatal age < 12 hours, the requirement for any form of positive pressure support (mechanical or nasal ventilation or CPAP) and parental consent for participation.
Are the trial subjects under 18? yes
Number of subjects for this age range: 100
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

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 exclude an infant for the mentioned reasons will be left to the discretion of the attending physician.

Study & Design

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