Effect of bronchoalveolar lavage-directed therapy on Pseudomonas aeruginosa infection and structural lung injury in children with cystic fibrosis: A randomized trial

Wainwright, Claire E., Vidmar, Suzanna, Armstrong, David S., Byrnes, Catherine A., Carlin, John B., Cheney, Joyce, Cooper, Peter J., Grimwood, Keith, Moodie, Marj, Robertson, Colin F. and Tiddens, Harm A. (2011) Effect of bronchoalveolar lavage-directed therapy on Pseudomonas aeruginosa infection and structural lung injury in children with cystic fibrosis: A randomized trial. JAMA: Journal of the American Medical Association, 306 2: 163-171. doi:10.1001/jama.2011.954


Author Wainwright, Claire E.
Vidmar, Suzanna
Armstrong, David S.
Byrnes, Catherine A.
Carlin, John B.
Cheney, Joyce
Cooper, Peter J.
Grimwood, Keith
Moodie, Marj
Robertson, Colin F.
Tiddens, Harm A.
Title Effect of bronchoalveolar lavage-directed therapy on Pseudomonas aeruginosa infection and structural lung injury in children with cystic fibrosis: A randomized trial
Formatted title
Effect of bronchoalveolar lavage-directed therapy on Pseudomonas aeruginosa infection and structural lung injury in children with cystic fibrosis: A randomized trial
Journal name JAMA: Journal of the American Medical Association   Check publisher's open access policy
ISSN 0098-7484
1538-3598
Publication date 2011-07-13
Sub-type Article (original research)
DOI 10.1001/jama.2011.954
Volume 306
Issue 2
Start page 163
End page 171
Total pages 9
Place of publication Chicago, IL, U.S.A.
Publisher American Medical Association
Collection year 2012
Language eng
Formatted abstract
Context 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.

Design, Setting, and Participants 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.

Interventions 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.

Main Outcome Measures 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).

Conclusion 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.

Trial Registration anzctr.org.au Identifier: ACTRN12605000665639
Keyword Resolution computed-tomography
Oropharyngeal cultures
Airway inflammation
Young-children
Dornase-alpha
New-Zealand
Disease
Infants
Prevalence
Management
Dornase-α
Bronchoalveolar lavage
Children's health
Cystic fibrosis
Infant
Lung injury
Pseudomonas aeruginosa
Randomized trials
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: Official 2012 Collection
School of Medicine Publications
 
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