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AAP Grand Rounds 21:62 (2009) To Treat or Not to Treat Irritable Infants With Presumed GERDSource: Orenstein SR, Hassall E, Furmaga-Jablonska W, et al. Multicenter, double-blind, randomized, placebo-controlled trial assessing the efficacy and safety of proton pump inhibitor lansoprazole in infants with symptoms of gastroesophageal reflux disease. Pediatrics. 2009;154(4):514–520.e4. Epub 2008 Dec 3. doi:10.1016/j.jpeds.2008.09.054[CrossRef]
Investigators from 16 centers in the US and Poland studied the efficacy and safety of lansoprazole (a proton pump inhibitor) for the treatment of infants with symptoms of gastroesophageal refux disease (GERD) between 2006 and 2007. Primary symptoms were defined as crying, irritability, or fussiness during or within one hour after feeding despite more than one week of non-pharmacologic management (NPM). NPM was defined as environmental (eg, avoiding smoke exposure), feeding changes, and position changes. Infants who weighed >2 kg and had daily diary-documented crying for
Eligible infants were randomized to lansoprazole or placebo. Lansoprazole was administered once daily for four weeks at a dose of 0.2 to 0.3 mg/kg per day for infants
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