IS-003 Early Inhaled Corticosteroids For The Prevention Of Bronchopulmonary Dysplasia In Extremely Preterm Infants: The Neonatal European Study Of Inhaled Steroids (neurosis)

BackgroundSurvival of extremely low birth weight (ELBW) infants has improved in recent decades but bronchopulmonary dysplasia (BPD) remains a major problem. The effect of early inhalation of corticosteroids on survival without BPD in these infants is unclear.ObjectiveTo determine the effect of early...

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Bibliographic Details
Published in:Archives of disease in childhood 2014-10, Vol.99 (Suppl 2), p.A1-A2
Main Authors: Bassler, D, Carnielli, V, Halliday, HL, Hallman, M, Jarreau, PH, Plavka, R, Schwab, M, Shinwell, ES, van den Anker, J, Poets, CF
Format: Article
Language:English
Subjects:
Age
Body Weight
Budesonide
Corticosteroids
Dysplasia
Gestational age
Infants
Inhalation
Low birth weight
Lung diseases
Neonates
Neurosis
Newborn babies
Premature babies
Pressure
Respiratory therapy
Statistical Significance
Steroid hormones
Survival
Young Children
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Summary:BackgroundSurvival of extremely low birth weight (ELBW) infants has improved in recent decades but bronchopulmonary dysplasia (BPD) remains a major problem. The effect of early inhalation of corticosteroids on survival without BPD in these infants is unclear.ObjectiveTo determine the effect of early use of inhaled budesonide in infants with gestational ages of 23 0/7–27 6/7 weeks requiring any form of positive pressure support on survival without BPD at 36 weeks’ gestational age.MethodsRandomised controlled trial. Budesonide or placebo were continued until infants were either off supplementary oxygen and positive pressure support or had reached a gestational age of 32 0/7 weeks regardless of their ventilator status. The primary outcome was death before 36 weeks of gestational age or survival with BPD, defined according to the physiological definition.ResultsWe randomly assigned 863 infants during the first 12 h of life in 40 centres in 9 countries to inhaled budesonide or placebo. In 7 infants consent was withdrawn. Of the 437 infants assigned to inhaled budesonide, 175 died or survived with BPD (40.0%), as compared with 194 of 419 infants assigned to placebo (46.3%). Further results are shown in the table.Abstract IS-003 Table 1ConclusionsThe reduction of the primary outcome (death before 36 weeks or BPD) by inhaled budesonide in ELBW infants was of borderline statistical significance. Inhaled budesonide significantly reduced BPD, which is a component of our primary outcome and was a predefined secondary outcome.
ISSN:0003-9888
1468-2044
DOI:10.1136/archdischild-2014-307384.3