Fluticasone inhalation in moderate cases of bronchopulmonary dysplasia.
OBJECTIVE
This randomized, controlled trial was designed to determine the efficacy of inhaled fluticasone propionate on oxygen therapy weaning in a population of preterm infants who were born at <32 weeks of gestation and experienced moderate bronchopulmonary dysplasia (BPD).


METHODS
Thirty-two infants who were < or =32 weeks of gestation, had moderate BPD that required supplemental oxygen (fraction of inspired oxygen > or =0.25), and were aged between 28 and 60 days were randomized. Fluticasone propionate 125 microg twice daily for 3 weeks and once daily for a fourth week was delivered to infants who weighed between 500 and 1200 g. The dosage was doubled for infants who weighed > or =1200 g.


RESULTS
Compared with placebo, treatment had no effect on either duration of supplemental O2 therapy or ventilatory support as assessed by survival analysis. At 28 days, a trend toward a lower cortisol/creatinine ratio in the treatment group was noted compared with placebo (25.1 +/- 18.9 vs 43 +/- 14.4). In the fluticasone group at 28 days, the systolic arterial pressure (78 +/- 3 vs 68 +/- 3 mm Hg) and diastolic arterial pressure (43 +/- 3.4 mm Hg vs 38 +/- 2.0 mm Hg) were higher compared with baseline fluticasone values. The chest radiograph score was lower than baseline (2.8 +/- 1.4 vs 3.7 +/- 2.2) in the fluticasone group at 28 days. This study has a statistical power of 1.0 to detect a significant difference in the duration of oxygen supplementation of >21 days between the study groups.


CONCLUSIONS
We conclude that fluticasone propionate reduces neither supplemental O2 use nor the need for ventilatory support in this patient population. However, fluticasone does have a positive radiologic effect in lowering chest radiograph scores. In addition, our data point to a possible association among inhaled fluticasone treatment and higher arterial blood pressure. Thus, the results of this investigation do not support the use of inhaled corticosteroids in the treatment of oxygen-dependent infants who have established moderate BPD.
Dugas
Marc-André
MA
Department of Pediatrics, Centre Hospitalier Universitaire de Québec, Université Laval, Quebec, Quebec, Canada.
Nguyen
Diep
D
Frenette
Lyne
L
Lachance
Christian
C
St-Onge
Odette
O
Fougères
Annie
A
Bélanger
Sylvie
S
Caouette
Georges
G
Proulx
Eric
E
Racine
Marie-Claude
MC
Piedboeuf
Bruno
B
D000280:Administration, Inhalation; D000730:Androstadienes / Q000494:pharmacology / Q000627:therapeutic use*; D000893:Anti-Inflammatory Agents / Q000494:pharmacology / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects; D001997:Bronchopulmonary Dysplasia / Q000188:drug therapy*; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D005260:Female; D000068298:Fluticasone; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007234:Infant, Premature; D007902:Length of Stay; D008297:Male; D010102:Oxygen Inhalation Therapy; D012121:Respiration, Artificial; D016019:Survival Analysis; D017211:Treatment Failure
D000730:Androstadienes; D000893:Anti-Inflammatory Agents; D000068298:Fluticasone