MedicalResearch.com Interview with:
Prof. Dr. Dirk Bassler, MSc
Department of Neonatology
Zurich Switzerland
Medical Research: What is the background for this study? What are the main findings?
Response: The lungs of preterm infants are very vulnerable and these infants frequently develop chronic lung disease, also called bronchopulmonary dysplasia (BPD). BPD is not only a problem of the lungs, it is also a major cause of early death in these infants and if they survive, their risks of respiratory problems in later life and neurodevelopmental impairment are increased when compared to infants without bronchopulmonary dysplasia. Few drugs are available to prevent or to treat BPD and up to this date, no licensed drug for this indication is on the market, neither in Europe nor the USA. Hence additional preventive strategies are needed to reduce the risk of BPD and inhaled glucocorticoids seemed to have a favorable benefit-risk ratio.
Medical Research: What are the main findings?
Response: A total of 863 preterm infants with a gestational age of less than 28 weeks from 40 study centers in 9 countries (8 European countries and Israel) participated in the
Neonatal
European
Study of
Inhaled
Steroids (
NEUROSIS). The study investigated whether inhaled budesonide, an anti-inflammatory glucocorticoid, would decrease the incidence of bronchopulmonary dysplasia and death in preterm infants. The results show for the first time that inhaled budesonide reduces the incidence of BPD in preterm infants, a finding that is statistically significant. However, in absolute numbers, more infants died during the study period in the budesonide group compared to the placebo group. This difference is not statistically significant and could be caused by chance. Budesonide had a statistically significant positive effect on two more prespecified secondary outcomes: it reduced the rate of infants requiring intubation after completion of study treatment and the frequency of surgery required to close a patent ductus arteriosus, a blood vessel connecting the pulmonary artery to the aorta. The rate of side effects was similar in the budesonide and in the placebo group.
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