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Published on: May 4, 2020
Early inhaled budesonide in extremely preterm infants decreases long-term respiratory morbidity
Jana Tukova1, Jan Smisek2, Blanka Zlatohlavkova2,3
1Department of Paediatrics and Adolescent Medicine, Centre for Follow-Up Care of Ex-Preterm Babies, First Faculty of Medicine, Charles University and General University Hospital in Prague, Prague, Czech Republic.
Insights
Early inhaled budesonide in infants may reduce chronic lung disease symptoms. Long-term lung function showed a trend toward improvement, but further research is needed for definitive outcomes.
Area of Science:
- Neonatal respiratory health
- Pediatric pulmonology
- Pharmacological interventions in infants
Background:
- Bronchopulmonary dysplasia (BPD) incidence may be reduced by early inhaled corticosteroids, but long-term respiratory outcomes are not well-established.
- The correlation between early BPD and later respiratory disease is not definitively understood.
Purpose of the Study:
- To investigate the long-term effects of early inhaled corticosteroids on chronic respiratory morbidity in infants.
- To assess objective lung function in children previously treated with inhaled budesonide during their neonatal period.
Main Methods:
- Follow-up of 59 survivors from the Neonatal European Study of Inhaled Steroids (NESIS) cohort.
- Monitoring respiratory morbidity in the first 2 years and performing lung function tests at approximately 5.9 years of age.
- Randomized comparison of inhaled budesonide versus placebo, with outcomes analyzed before subgroup unblinding.
Main Results:
- No statistically significant differences in spirometry parameters (FEF, FEV1, FVC, FEV1/FVC) between budesonide and placebo groups.
- A trend towards improved expiratory flow patterns was observed in the budesonide group.
- Children receiving budesonide showed a significantly lower incidence of chronic lung disease symptoms (34.6% vs. 68.2%, P=0.04).
Conclusions:
- Early inhaled budesonide administration in neonates is associated with a trend towards improved functional lung parameters.
- Inhaled budesonide demonstrated a significant reduction in the rate of chronic lung disease symptoms within the first two years of life.
- Further investigation is warranted to fully elucidate the long-term respiratory benefits of early inhaled corticosteroid use.
Background:
There is no strict correlation between early bronchopulmonary dysplasia and long-term respiratory disease. Early inhaled corticosteroids seem to reduce the incidence of bronchopulmonary dysplasia, but the long-term outcome remains unknown.
Research Question:
The aim of this study was to evaluate the effect of early inhaled corticosteroids on chronic respiratory morbidity.
Methods:
Fifty-nine survivors from the Prague cohort included in Neonatal European Study of Inhaled Steroids underwent further follow-up comprising of respiratory morbidity monitoring during the first 2 years of life followed by objective lung function testing performed at the age of 5.9 years (range 5-7 years). Both outcomes were pursued and finalized before the unblinding of budesonide subgroups.
Results:
Fifty randomized (budesonide vs placebo group, 56% vs 44%) survivors were included in the study. Spirometry was successfully performed in 48 children. No statistically significant differences were found in the lung function test (forced expiratory flow [FEF] - FEF75 , FEF50, FEF25 , and FEF25-75; FEV1 , forced vital capacity [FVC], FEV1 /FVC) although mild trend to the improvement of expiratory flow pattern was observed in the budesonide group (median z-score of FEV1 /FVC -0.376 vs -0.983, P = .13; median z-score of FEF25-75 -1.004 vs -1.458, P = .13; median z-score of FEF75 -0.527 vs -0.996, P = .17). Children assigned to budesonide had a significantly lower rate of symptoms of chronic lung disease (34.6% vs 68.2%; P = .04) than children assigned to placebo.
Interpretation:
Our study suggests that early inhaled budesonide was associated with the trend to the improvement of functional lung parameters and with a lower rate of symptoms of chronic lung disease within the first 2 years of life.
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