10.6084/m9.figshare.4929740.v1
Koch A.
Koch
A.
Kreutzer K.
Kreutzer
K.
von Oldershausen G.
von Oldershausen G.
Poets C.F.
Poets
C.F.
Bassler D.
Bassler
D.
on behalf of the NEuroSIS Trial Group
on behalf of the NEuroSIS Trial
Group
Supplementary Material for: Inhaled Glucocorticoids and Pneumonia in Preterm Infants: Post Hoc Results from the NEuroSIS Trial
Karger Publishers
2017
Pneumonia
Preterm infants
Inhaled glucocorticoids
Budesonide
Infection
2017-04-28 10:16:51
Journal contribution
https://karger.figshare.com/articles/journal_contribution/Supplementary_Material_for_Inhaled_Glucocorticoids_and_Pneumonia_in_Preterm_Infants_Post_Hoc_Results_from_the_NEuroSIS_Trial/4929740
<p><b><i>Background:</i></b> Inhaled glucocorticoids may increase the
risk of pneumonia in adults. Thus, respiratory infections may be a
potential explanation for the non-significantly increased mortality seen
in the glucocorticoid group in the largest randomized trial on inhaled
glucocorticoids for preventing bronchopulmonary dysplasia in preterm
infants published to date (NEuroSIS). <b><i>Objective:</i></b> To evaluate the effect of inhaled budesonide on the risk of death due to respiratory infections in the NEuroSIS trial. <b><i>Methods:</i></b>
We performed post hoc analyses of prospectively collected data from 856
preterm infants on presumed but not culture-proven sepsis and
antimicrobial drug use. Additionally, pulmonary complications reported
on adverse event forms, death certificates and autopsy reports were
compared between study groups. <b><i>Results:</i></b> Treatment groups
did not differ in the number of episodes with suspected sepsis (184/437
[42.1%] in the budesonide vs. 171/419 [40.8%] in the placebo group).
Neither the number of patients receiving antimicrobial drugs nor the
length of antimicrobial treatment differed between groups. Our analyses
for pulmonary adverse events as well as for pulmonary complications
reported on death certificates and autopsy reports did not suggest a
negative impact of inhaled budesonide on these outcomes. <b><i>Conclusion:</i></b>
The current analysis does not support the assumption that respiratory
tract infections explain the increased mortality seen in the
glucocorticoid group in the NEuroSIS trial.</p>