title: Inhaled hydrofluoalkane-beclomethasone dipropionate in bronchopulmonary dysplasia. A double-blind, randomized, controlled pilot study.
abstract: The efficacy of inhaled steroids in spontaneously breathing infants with established bronchopulmonary dysplasia (BPD) is debatable. The inhaled steroid hydrofluoalkane-beclomethasone dipropionate (QVAR) is unique in its small particle size that results in higher lung deposition. Our objective was to determine if inhaled QVAR could decrease respiratory rehospitalizations of infants with established BPD.
  
  
  
  Double-blind, randomized placebo-controlled, multicenter pilot study. Preterm infants with moderate-to-severe BPD were randomized to inhaled QVAR 100 μg per dose or placebo twice daily via Aerochamber with face mask. Treatment was administered daily from recruitment at 36 weeks post menstrual age until 3 months post discharge. Analysis was carried out by intention to treat.
  
  
  
  The QVAR (n=18) and placebo (n=20) groups were comparable in birth and recruitment characteristics. Length of stay (108.5±26.3 vs 108.7±36.0 days) and infants requiring oxygen at discharge (5/17 vs 6/19) or at study end (0/17 vs 2/19) were comparable. Respiratory rehospitalizations/infant (0.1±0.5 vs 0.4±0.6), rehospitalization days (0.5±1.5 vs 4.1±10.3), and post-discharge additive inhaled (0.3±0.9 vs 6.4±21.5 days), systemic (0.7±2.8 vs 1.0±1.4 days) and combined (inhaled/systemic) steroids (1.0±2.9 vs 7.8±25.8 days) tended to be lower in the QVAR compared with the placebo group. Blood pressure, height and weight gain, and urine cortisol/creatinine ratio at study end were comparable between groups.
  
  
  
  Our study was unable to detect a significant effect of inhaled QVAR on the respiratory course of established BPD. The study was underpowered. Possible benefits of QVAR could be masked by a tendency toward higher use of additional steroids in the placebo group.
authors.affiliation: Department of Neonatology and Pediatric Pulmonary Unit, Bnai Zion Medical Center, Haifa, Israel.|The B&R Rappaport Faculty of Medicine, Haifa, Israel.
authors.forename: A
authors.initials: A
authors.lastname: Kugelman
authors.affiliation: The B&R Rappaport Faculty of Medicine, Haifa, Israel.|Department of Neonatology, Haemek Medical Center, Afula, Israel.
authors.forename: M
authors.initials: M
authors.lastname: Peniakov
authors.affiliation: Department of Neonatology, Barzilai Medical Center, Ashkelon, Israel.|Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva, Israel.
authors.forename: S
authors.initials: S
authors.lastname: Zangen
authors.affiliation: The B&R Rappaport Faculty of Medicine, Haifa, Israel.|Department of Neonatology, Laniado Medical Center, Netanya, Israel.
authors.forename: Y
authors.initials: Y
authors.lastname: Shiff
authors.affiliation: Department of Neonatology and Pediatric Pulmonary Unit, Bnai Zion Medical Center, Haifa, Israel.|The B&R Rappaport Faculty of Medicine, Haifa, Israel.
authors.forename: A
authors.initials: A
authors.lastname: Riskin
authors.affiliation: Department of Neonatology and Pediatric Pulmonary Unit, Bnai Zion Medical Center, Haifa, Israel.|The B&R Rappaport Faculty of Medicine, Haifa, Israel.
authors.forename: A
authors.initials: A
authors.lastname: Iofe
authors.affiliation: Department of Neonatology and Pediatric Pulmonary Unit, Bnai Zion Medical Center, Haifa, Israel.|The B&R Rappaport Faculty of Medicine, Haifa, Israel.
authors.forename: I
authors.initials: I
authors.lastname: Shoris
authors.affiliation: Department of Neonatology and Pediatric Pulmonary Unit, Bnai Zion Medical Center, Haifa, Israel.|The B&R Rappaport Faculty of Medicine, Haifa, Israel.
authors.forename: D
authors.initials: D
authors.lastname: Bader
authors.affiliation: Department of Neonatology, Meir Medical Center, Kfar Saba, Israel.|Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
authors.forename: S
authors.initials: S
authors.lastname: Arnon
mesh_terms: D000280:Administration, Inhalation; D001507:Beclomethasone / Q000008:administration & dosage*; D001997:Bronchopulmonary Dysplasia / Q000628:therapy*; D004311:Double-Blind Method; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage*; D006801:Humans; D007223:Infant; D062071:Infant, Extremely Premature; D007231:Infant, Newborn; D019102:Infant, Very Low Birth Weight; D007557:Israel; D007902:Length of Stay / Q000706:statistics & numerical data; D008297:Male; D010359:Patient Readmission / Q000706:statistics & numerical data; D010865:Pilot Projects; D012121:Respiration, Artificial / Q000379:methods; D016896:Treatment Outcome
chemical_list: D005938:Glucocorticoids; D001507:Beclomethasone