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Efficacy of a Pre-thickened Infant Formula: A Multicenter, Double-Blid, Randomized, Placebo-Controlled Parallel Group Trial in 104 Infants with Symptomatic Gastroesophageal Reflux

Joint Section of Pediatric Gastroenterology and Nutrition, University of Nebraska Medical Center and Creighton University, Omaha, Nebraska

J. Roberto Moran, MD

Cheryl L. Harris, MS

Kimberly L. Merkel, RPh

Mead Johnson Nutritionals, Evansville,Indiana

Susan R. Orenstein, MD

Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania

To evaluate a pre-thickened formula (Enfamil AR1/2) for regurgitant gastroesophageal reflux, 104 infants were enrolled in a 5-week, multi center, double-blind, randomized, place bo controlled parallel group trial. The Enfamil AR group showed greater symptom reduction by the end of the first week: percent feedings with any regurgitation (p=0.045), total regurgitation volume score (p=0.035), and percent feedings with choke-gag-cough (p=0.00⁴). The most symptomatic infants at baseline had a reduction in trouble sleeping significantly with Enfamil AR by the end of the study (p=0.030). This formula flows through a standard nipple, reduces regurgitation and choking-gagging-coughing within a week, and improves sleep in the most symptomatic babies by 5 weeks, without causing constipation.

Clinical Pediatrics, Vol. 42, No. 6, 483-495 (2003)
DOI: 10.1177/000992280304200602


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