Early inhaled glucocorticoid therapy to prevent bronchopulmonary dysplasia.
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.
Cole
C H
CH
Department 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
Colton
T
T
Shah
B L
BL
Abbasi
S
S
MacKinnon
B L
BL
Demissie
S
S
Frantz
I D
ID
D000280:Administration, Inhalation; D001507:Beclomethasone / Q000008:administration & dosage*; D001993:Bronchodilator Agents / Q000627:therapeutic use; D001997:Bronchopulmonary Dysplasia / Q000517:prevention & control*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage*; D006801:Humans; D007231:Infant, Newborn; D007234:Infant, Premature; D008297:Male; D010102:Oxygen Inhalation Therapy; D012121:Respiration, Artificial / Q000706:statistics & numerical data; D012127:Respiratory Distress Syndrome, Newborn / Q000188:drug therapy* / Q000628:therapy
D001993:Bronchodilator Agents; D005938:Glucocorticoids; D001507:Beclomethasone