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ORIGINAL CONTRIBUTION ONLINE FIRST Inhaled Hypertonic Saline in Infants and Children Younger Than 6 Years With Cystic Fibrosis The ISIS Randomized Controlled Trial Margaret Rosenfeld, MD, MPH Context Inhaled hypertonic saline is recommended as therapy for patients 6 years Felix Ratjen, MD, PhD or older with cystic fibrosis (CF), but its efficacy has never been evaluated in patients younger than 6 years with CF. Lyndia Brumback, PhD Objective To determine if hypertonic saline reduces the rate of protocol-defined pul- Stephen Daniel, PhD monary exacerbations in patients younger than 6 years with CF. Ron Rowbotham, MS Design, Setting, and Participants The Infant Study of Inhaled Saline in Cystic Sharon McNamara, MN Fibrosis (ISIS), a multicenter, randomized, double-blind, placebo-controlled trial con- ducted from April 2009 to October 2011 at 30 CF care centers in the United States Robin Johnson, RRT and Canada. Participants were aged 4 to 60 months and had an established diagnosis Richard Kronmal, PhD of CF. A total of 344 patients were assessed for eligibility; 321 participants were ran- Stephanie D. Davis, MD domized; 29 (9%) withdrew prematurely. for the ISIS Study Group Intervention The active treatment group (n=158) received 7% hypertonic saline and the control group (n=163)
JAMA – American Medical Association
Published: Jun 6, 2012
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