Published online April 15, 2005
PEDIATRICS (doi:10.1542/peds.2004-0951)
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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 ≤32 weeks of gestation, had moderate BPD that required supplemental oxygen (fraction of inspired oxygen ≥0.25), and were aged between 28 and 60 days were randomized. Fluticasone propionate 125 µg 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 ≥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.

CONCLUSION.: 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.

Marc-André Dugas, MD*, Diep Nguyen, MD*, Lyne Frenette, MD*, Christian Lachance, MD{ddagger}, Odette St-Onge, MD§, Annie Fougères, MD§, Sylvie Bélanger, MD*, Georges Caouette, MD*, Eric Proulx, PharmD||, Marie-Claude Racine, PharmD|| and Bruno Piedboeuf, MD*

* Departments of Pediatrics
§ Radiology
|| Pharmacy, Centre Hospitalier Universitaire de Québec, Université Laval, Quebec, Quebec, Canada
{ddagger} Department of Pediatrics, Hôpital Sainte-Justine, Université de Montréal, Montreal, Quebec, Canada

Key Words: neonatal bronchopulmonary dysplasia • clinical trial • glucocorticoids • oxygen inhalation therapy

Abbreviations: BPD, bronchopulmonary dysplasia • FIO2, fraction of inspired oxygen

Accepted Nov 16, 2004.


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