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Vol. 21 No. 6, June 2009
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AAP Grand Rounds 21:62 (2009)
© 2009 American Academy of Pediatrics

GASTROENTEROLOGY, HEPATOLOGY & NUTRITION

To Treat or Not to Treat Irritable Infants With Presumed GERD

Source: 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]

The first 20% of the full text of this article appears below.


PICO

Question: Among infants with persistent symptoms attributed to gastroesophageal reflux, how effective and safe is lansoprazole?

Question type: Intervention

Study design: Multicenter, randomized trial

 

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 ≥25 % of feeds were included. Infants with congenital anomalies, unstable severe disease, or tube feedings were excluded.

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 ≤ 10 weeks of age and 1.0 to 1.5 mg/kg per . . . [Full Text of this Article]

Chandran Alexander, MD and Neal LeLeiko, MD, PhD, FAAP
Hasbro Children’s Hospital/Rhode Island Hospital and Warren Alpert Medical School of Brown University, Providence, RI