Chronic lung disease (CLD) of prematurity or bronchopulmonary dysplasia (BPD)
Conditions
Interventions
Within 2 years 850 infants of 23-27 weeks GA will be randomised during the
first 12 hours of life to Budesonide (BS) of placebo to prevent BPD. Study
drugs will be administered via Aerochamber and c
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
2 Years to 11 Years
Inclusion criteria
Inclusion criteria: - gestational age of 23 0/7-27 6/7 weeks, - postnatal age
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is defined as a combination of BPD or death at 36 weeks gestational age. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Neurodevelopmental outcomes at 18 - 22 months; - Adverse treatment effects; - Mortality at 36 weeks gestationale age; - BPD incidence at 36 weeks gestational age; - Duration of positive pressure respiratory support or supplemental oxygen. | — |
Countries
Netherlands
Outcome results
None listed