Long-Term Effects of Inhaled Budesonide for Bronchopulmonary Dysplasia
Jazyk angličtina Země Spojené státy americké Médium print
Typ dokumentu časopisecké články, multicentrická studie, randomizované kontrolované studie, práce podpořená grantem
PubMed
29320647
DOI
10.1056/nejmoa1708831
Knihovny.cz E-zdroje
- MeSH
- aplikace inhalační MeSH
- bronchopulmonální dysplazie prevence a kontrola MeSH
- budesonid aplikace a dávkování MeSH
- gestační stáří MeSH
- glukokortikoidy aplikace a dávkování MeSH
- kognitivní poruchy epidemiologie MeSH
- lidé MeSH
- mozková obrna epidemiologie MeSH
- následné studie MeSH
- nedoslýchavost epidemiologie MeSH
- nemoci nedonošenců mortalita MeSH
- novorozenci extrémně nezralí * MeSH
- novorozenec MeSH
- slepota epidemiologie MeSH
- vývojové poruchy u dětí epidemiologie MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- novorozenec MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- Názvy látek
- budesonid MeSH
- glukokortikoidy MeSH
BACKGROUND: The long-term effects on neurodevelopment of the use of inhaled glucocorticoids in extremely preterm infants for the prevention or treatment of bronchopulmonary dysplasia are uncertain. METHODS: We randomly assigned 863 infants (gestational age, 23 weeks 0 days to 27 weeks 6 days) to receive early (within 24 hours after birth) inhaled budesonide or placebo. The prespecified secondary long-term outcome was neurodevelopmental disability among survivors, defined as a composite of cerebral palsy, cognitive delay (a Mental Development Index score of <85 [1 SD below the mean of 100] on the Bayley Scales of Infant Development, Second Edition, with higher scores on the scale indicating better performance), deafness, or blindness at a corrected age of 18 to 22 months. RESULTS: Adequate data on the prespecified composite long-term outcome were available for 629 infants. Of these infants, 148 (48.1%) of 308 infants assigned to budesonide had neurodevelopmental disability, as compared with 165 (51.4%) of 321 infants assigned to placebo (relative risk, adjusted for gestational age, 0.93; 95% confidence interval [CI], 0.80 to 1.09; P=0.40). There was no significant difference in any of the individual components of the prespecified outcome. There were more deaths in the budesonide group than in the placebo group (82 [19.9%] of 413 infants vs. 58 [14.5%] of 400 infants for whom vital status was available; relative risk, 1.37; 95% CI, 1.01 to 1.86; P=0.04). CONCLUSIONS: Among surviving extremely preterm infants, the rate of neurodevelopmental disability at 2 years did not differ significantly between infants who received early inhaled budesonide for the prevention of bronchopulmonary dysplasia and those who received placebo, but the mortality rate was higher among those who received budesonide. (Funded by the European Union and Chiesi Farmaceutici; ClinicalTrials.gov number, NCT01035190 .).
Citace poskytuje Crossref.org
European Consensus Guidelines on the Management of Respiratory Distress Syndrome: 2022 Update
European Consensus Guidelines on the Management of Respiratory Distress Syndrome - 2019 Update
ClinicalTrials.gov
NCT01035190, NCT01035190