In one of the largest randomized neonatal studies ever conducted in Europe, researchers from nine countries have demonstrated that budesonide has apositive effect on the prevention of chronic lung disease in premature babies.
Chronic lung disease is one of the most serious diseases facing children who are born prematurely. The lead scientist on the study was Prof. Dr. Dirk Bassler, Director of the Department of Neonatology at University Hospital Zurich.
Babies who come into the world prematurely have very sensitive lungs. As a result, they often develop chronic lung disease, which can have a serious impact on their lives in the future. Potential consequences of chronic lung disease include death during infancy and impaired mental and physical development if the affected child survives.
The causes of chronic lung disease, also known as bronchopulmonary dysplasia, are manifold. “Nature did not expect the lungs to have to function at such an early stage, and inflammatory processes caused by a variety of factors often lead to additional lung damage,” says Prof. Dr. Dirk Bassler, Director of the Department of Neonatology at University Hospital Zurich and leading author of the study published on 15 October in the New England Journal of Medicine.
Premature babies are often ignored by the pharmaceutical industry
Doctors caring for premature babies are faced with a lack of medication to treat bronchopulmonary dysplasia. To this day, there is no medication in Europe or the USA approved for the prevention or treatment of bronchopulmonary dysplasia.
This is partly because it is often not worthwhile for the pharmaceutical industry to invest in costly studies and approval procedures, as premature babies are a relatively small group and therefore do not constitute a lucrative market. Consequently, studies organized directly by doctors take on an even greater significance in this group of patients.
Bronchopulmonary dysplasia is sometimes treated using glucocorticoids, a class of steroid hormone. Now, a large-scale study has investigated whether inhaling budesonide, a synthetic anti-inflammatory agent in the glucocorticoid family, has an effect on bronchopulmonary dysplasia and the survival of premature babies.
For the Neonatal European Study of Inhaled Steroids (NEUROSIS), 40 study centers across 9 countries enrolled 863 premature babies born before the 28th week of pregnancy. This makes NEUROSIS one of the largest ever randomized studies of premature babies to have been initiated in Europe. The lead scientist was Dirk Bassler from Tübingen, and the study was coordinated by Prof. Dr. Christian Poets, Director of the Department of Neonatology at University Children’s Hospital in Tübingen, Germany.
NEUROSIS was financed by European Union funding under the 7th framework program for research. “However, the study would not have been possible without the support of many families, committed doctors and scientists in Europe and Israel,” say Bassler and Poets.
Fewer cases of lung disease and less need for artificial ventilation
The results show clearly, and for the first time, that the inhalation of budesonide yields a statistically significant reduction in the incidence of bronchopulmonary dysplasia in premature babies. On the other hand, the absolute number of children who died during the study period was higher in the treatment group than in the group receiving a placebo.
However, this difference is not statistically significant. This means that this could be a chance finding that has nothing to do with inhalation therapy, as is reported in the New England Journal of Medicine. In the group of children treated with budesonide, the need for artificial respiration after the trial medication was stopped in accordance with the study protocol was also significantly lower.
The same is true of the need for surgical closure of a blood-vessel connection between the aorta and the pulmonary artery. Side effects had an equal rate of incidence in the treatment and placebo groups.
The study’s results represent an important additional finding since inhaled glucocorticoids are used widely on neonatal wards in Europe and the USA, although before the NEUROSIS results were published, little was known about the benefits and risks of this treatment.
Above all, it will be the study’s long-term results that determine whether the administration of budesonide via inhalation will become established clinical practice for preventing chronic lung disease in premature babies. The NEUROSIS study protocol stipulates that the premature babies will undergo follow-up examinations when they are 18–22 months old.
Dirk Bassler, M.D., Richard Plavka, M.D., Ph.D., Eric S. Shinwell, M.D., Mikko Hallmann, M.D., Ph.D., Pierre-Henri Jarreau, M.D., Ph.D., Virgilio Carnielli, M.D., Johannes N. van den Anker, M.D., Ph.D., Christoph Meisner, Ph.D., Corinna Engel, Ph.D., Matthias Schwab, M.D., Henry L. Halliday, M.D., and Christian F. Poets, M.D., for the NEUROSIS Trial Group.
Early Inhaled Budesonide for the Prevention of Bronchopulmonary Dysplasia, New England Journal of Medicine, 373;16, 1497-1506.
Contact in case of queries:
Prof. Dr. Dirk Bassler, MSc
Director, Department of Neonatology, University Hospital Zurich, firstname.lastname@example.org
Tel 044 255 86 20 (Corporate Communications)
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