eurosis.
Recruiting
- Conditions
- Randomised controlled trialPreterm infantsInhaled corticosteroidsBronchopulmonary dysplasiaGerandomiseerd gecontroleerd onderzoekPrematuur geboren kinderenInhalatiecorticosteroïdenBronchopulmonale dysplasie
- Registration Number
- NL-OMON29190
- Lead Sponsor
- eurosis Study Center, Prof. Dr. med. Christian-F. Poets en PD. Dr. med Dirk Bassler, MSc Medical University - Tuebingen GermanyNeurosis study Center, neurosis.studycoordinator@med.uni-tuebingen.de
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
1. Gestational age of 23 0/7-27 6/7 weeks;
2. Postnatal age < 12 hours;
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome is defined as a combination of BPD or death at 36 weeks gestational age.
- Secondary Outcome Measures
Name Time Method 1. Neurodevelopmental outcomes at 18 - 22 months;<br /><br>2. Adverse treatment effects;<br /><br>3. Mortality at 36 weeks gestationale age;<br /><br>4. BPD incidence at 36 weeks gestational age;<br /><br>5. Duration of positive pressure respiratory support or supplemental oxygen.