title: Effect of bronchoalveolar lavage-directed therapy on Pseudomonas aeruginosa infection and structural lung injury in children with cystic fibrosis: a randomized trial.
abstract: BACKGROUND
  Early pulmonary infection in children with cystic fibrosis leads to increased morbidity and mortality. Despite wide use of oropharyngeal cultures to identify pulmonary infection, concerns remain over their diagnostic accuracy. While bronchoalveolar lavage (BAL) is an alternative diagnostic tool, evidence for its clinical benefit is lacking.
  
  
  OBJECTIVE
  To determine if BAL-directed therapy for pulmonary exacerbations during the first 5 years of life provides better outcomes than current standard practice relying on clinical features and oropharyngeal cultures.
  
  
  METHODS
  The Australasian Cystic Fibrosis Bronchoalveolar Lavage (ACFBAL) randomized controlled trial, recruiting infants diagnosed with cystic fibrosis through newborn screening programs in 8 Australasian cystic fibrosis centers. Recruitment occurred between June 1, 1999, and April 30, 2005, with the study ending on December 31, 2009.
  
  
  METHODS
  BAL-directed (n = 84) or standard (n = 86) therapy until age 5 years. The BAL-directed therapy group underwent BAL before age 6 months when well, when hospitalized for pulmonary exacerbations, if Pseudomonas aeruginosa was detected in oropharyngeal specimens, and after P. aeruginosa eradication therapy. Treatment was prescribed according to BAL or oropharyngeal culture results.
  
  
  METHODS
  Primary outcomes at age 5 years were prevalence of P. aeruginosa on BAL cultures and total cystic fibrosis computed tomography (CF-CT) score (as a percentage of the maximum score) on high-resolution chest CT scan.
  
  
  RESULTS
  Of 267 infants diagnosed with cystic fibrosis following newborn screening, 170 were enrolled and randomized, and 157 completed the study. At age 5 years, 8 of 79 children (10%) in the BAL-directed therapy group and 9 of 76 (12%) in the standard therapy group had P. aeruginosa in final BAL cultures (risk difference, -1.7% [95% confidence interval, -11.6% to 8.1%]; P = .73). Mean total CF-CT scores for the BAL-directed therapy and standard therapy groups were 3.0% and 2.8%, respectively (mean difference, 0.19% [95% confidence interval, -0.94% to 1.33%]; P = .74).
  
  
  CONCLUSIONS
  Among infants diagnosed with cystic fibrosis, BAL-directed therapy did not result in a lower prevalence of P. aeruginosa infection or lower total CF-CT score when compared with standard therapy at age 5 years.
  
  
  BACKGROUND
  anzctr.org.au Identifier: ACTRN12605000665639.
authors.affiliation: Queensland Children's Medical Research Institute, and Queensland Children's Respiratory Centre, Royal Children's Hospital, University of Queensland, Brisbane, Australia. claire_wainwright@health.qld.gov.au
authors.forename: Claire E
authors.initials: CE
authors.lastname: Wainwright
authors.forename: Suzanna
authors.initials: S
authors.lastname: Vidmar
authors.forename: David S
authors.initials: DS
authors.lastname: Armstrong
authors.forename: Catherine A
authors.initials: CA
authors.lastname: Byrnes
authors.forename: John B
authors.initials: JB
authors.lastname: Carlin
authors.forename: Joyce
authors.initials: J
authors.lastname: Cheney
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Cooper
authors.forename: Keith
authors.initials: K
authors.lastname: Grimwood
authors.forename: Marj
authors.initials: M
authors.lastname: Moodie
authors.forename: Colin F
authors.initials: CF
authors.lastname: Robertson
authors.forename: Harm A
authors.initials: HA
authors.lastname: Tiddens
mesh_terms: D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D001315:Australia / Q000453:epidemiology; D018893:Bronchoalveolar Lavage; D002675:Child, Preschool; D003550:Cystic Fibrosis / Q000150:complications* / Q000000981:diagnostic imaging / Q000473:pathology*; D006760:Hospitalization; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008168:Lung / Q000503:physiopathology; D055370:Lung Injury / Q000209:etiology* / Q000517:prevention & control; D009520:New Zealand / Q000453:epidemiology; D015995:Prevalence; D011552:Pseudomonas Infections / Q000175:diagnosis* / Q000188:drug therapy* / Q000453:epidemiology; D012129:Respiratory Function Tests; D014057:Tomography, X-Ray Computed
chemical_list: D000900:Anti-Bacterial Agents