Efficacy of a pre-thickened infant formula: a multicenter, double-blind, randomized, placebo-controlled parallel group trial in 104 infants with symptomatic gastroesophageal reflux.
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.
Vanderhoof
Jon A
JA
Joint Section of Pediatric Gastroenterology and Nutrition, University of Nebraska Medical Center and Creighton University, Omaha, Nebraska, USA.
Moran
J Roberto
JR
Harris
Cheryl L
CL
Merkel
Kimberly L
KL
Orenstein
Susan R
SR
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