title: Efficacy of a pre-thickened infant formula: a multicenter, double-blind, randomized, placebo-controlled parallel group trial in 104 infants with symptomatic gastroesophageal reflux.
abstract: To evaluate a pre-thickened formula (Enfamil AR) for regurgitant gastroesophageal reflux, 104 infants were enrolled in a 5-week, multicenter, double-blind, randomized, placebo-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.
authors.affiliation: Joint Section of Pediatric Gastroenterology and Nutrition, University of Nebraska Medical Center and Creighton University, Omaha, Nebraska, USA.
authors.forename: Jon A
authors.initials: JA
authors.lastname: Vanderhoof
authors.forename: J Roberto
authors.initials: JR
authors.lastname: Moran
authors.forename: Cheryl L
authors.initials: CL
authors.lastname: Harris
authors.forename: Kimberly L
authors.initials: KL
authors.lastname: Merkel
authors.forename: Susan R
authors.initials: SR
authors.lastname: Orenstein
mesh_terms: D004311:Double-Blind Method; D005260:Female; D005764:Gastroesophageal Reflux / Q000178:diet therapy*; D006801:Humans; D007223:Infant; D041943:Infant Formula; D007231:Infant, Newborn; D008297:Male; D016896:Treatment Outcome