Efficacy and safety of inhaled Budesonide in Very Preterm Infants at Risk for Bronchopulmonary Dysplasia.

Phase 1

• Conditions: This trial will be conducted in a population of preterm infants who are at high risk of developing BPD. It will not only enroll infants requiring mechanical ventilation, but also infants on nasal ventilation or continuous positive airway pressure (CPAP). The latter group does not appear to be significantly affected by lung disease shortly after birth; however, it is at high risk of developing the new BPD.; MedDRA version: 8.1 Level: PT Classification code 10006475 Term: Bronchopulmonary Dysplasia

• Registration Number: EUCTR2009-012203-26-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-02-15
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 850

Inclusion Criteria

A gestational age of 23 0/7- 27 6/7 weeks, a postnatal age 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

A clinical decision not to administer therapies (infant not considered viable), dysmorphic features or congenital malformations that adversely affect life expectancy or neurodevelopment including all congenital pulmonary malformations, 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 aforementioned reasons will be left to the discretion of the attending physician.

Other exclusion criteria are: nosocomial pulmonary viral infections and hypersensitivity to any component of inhaled budesonide (budesonide itself, glycerol, ethanol, HFA-134A (norflurane)).

Study & Design

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