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Early inhaled glucocorticoid therapy to prevent bronchopulmonary dysplasia
1Department of Pediatrics, Floating Hospital for Children at New England Medical Center and Tufts University School of Medicine, Boston, MA 02111, USA. cynthia.cole@es.nemc.org
Insights
Early inhaled beclomethasone therapy in premature infants did not prevent bronchopulmonary dysplasia. However, it reduced the need for systemic glucocorticoids and mechanical ventilation.
Area of Science:
- Neonatal Medicine
- Respiratory Medicine
- Pharmacology
Background:
- Inhaled glucocorticoids are used for asthma, prompting investigation for preventing bronchopulmonary dysplasia in infants.
- Bronchopulmonary dysplasia (BPD) is a chronic lung disease affecting premature infants.
Purpose of the Study:
- To test if early inhaled glucocorticoid therapy decreases bronchopulmonary dysplasia frequency in premature infants.
- To evaluate the impact of inhaled beclomethasone on secondary outcomes like systemic glucocorticoid use and respiratory support duration.
Main Methods:
- A randomized, multicenter trial involving 253 premature infants (born <33 weeks gestation, weight ≤1250g) requiring ventilation.
- Infants received either inhaled beclomethasone or placebo for four weeks, with dosages decreasing over time.
- Primary outcome was BPD at 28 days; secondary outcomes included BPD at 36 weeks postmenstrual age, systemic glucocorticoid use, bronchodilator use, respiratory support duration, and mortality.
Main Results:
- The frequency of bronchopulmonary dysplasia was similar between beclomethasone (43% at 28 days, 18% at 36 weeks) and placebo (45% at 28 days, 20% at 36 weeks) groups.
- Infants receiving beclomethasone showed significantly lower rates of systemic glucocorticoid therapy (RR 0.6) and mechanical ventilation (RR 0.8) at 28 days.
Conclusions:
- Early beclomethasone therapy did not prevent bronchopulmonary dysplasia in premature infants.
- However, it was associated with reduced requirements for systemic glucocorticoid therapy and mechanical ventilation.
Background:
The safety and efficacy of inhaled glucocorticoid therapy for asthma stimulated its use in infants to prevent bronchopulmonary dysplasia. We tested the hypothesis that early therapy with inhaled glucocorticoids would decrease the frequency of bronchopulmonary dysplasia in premature infants.
Methods:
We conducted a randomized, multicenter trial of inhaled beclomethasone or placebo in 253 infants, 3 to 14 days old, born before 33 weeks of gestation and weighing 1250 g or less at birth, who required ventilation therapy. Beclomethasone was delivered in a decreasing dosage, from 40 to 5 microg per kilogram of body weight per day, for four weeks. The primary outcome measure was bronchopulmonary dysplasia at 28 days of age. Secondary outcomes included bronchopulmonary dysplasia at 36 weeks of postmenstrual age, the need for systemic glucocorticoid therapy, the need for bronchodilator therapy, the duration of respiratory support, and death.
Results:
One hundred twenty-three infants received beclomethasone, and 130 received placebo. The frequency of bronchopulmonary dysplasia was similar in the two groups: 43 percent in the beclomethasone group and 45 percent in the placebo group at 28 days of age, and 18 percent in the beclomethasone group and 20 percent in the placebo group at 36 weeks of postmenstrual age. At 28 days of age, fewer infants in the beclomethasone group than in the placebo group were receiving systemic glucocorticoid therapy (relative risk, 0.6; 95 percent confidence interval, 0.4 to 1.0) and mechanical ventilation (relative risk, 0.8; 95 percent confidence interval, 0.6 to 1.0).
Conclusions:
Early beclomethasone therapy did not prevent bronchopulmonary dysplasia but was associated with lower rates of use of systemic glucocorticoid therapy and mechanical ventilation.