EUCTR2009-012203-26-EE
Active, not recruiting
Phase 1
Efficacy and Safety of Inhaled Budesonide in Very Preterm Infants at Risk for Bronchopulmonary Dysplasia - NEUROSIS
niversitätsklinikum Tübingen0 sites863 target enrollmentApril 26, 2010
ConditionsHigh risk of bronchopulmonary dysplasia in very preterm neonatesMedDRA version: 12.1Level: LLTClassification code 10006475Term: Bronchopulmonary dysplasia
DrugsBudiair
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- High risk of bronchopulmonary dysplasia in very preterm neonates
- Sponsor
- niversitätsklinikum Tübingen
- Enrollment
- 863
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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).
Outcomes
Primary Outcomes
Not specified
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