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Clinical Pediatrics
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Clinical Response to 2 Commonly Used Switch Formulas Occurs within 1 Day

Carol Lynn Berseth, MD

Mead Johnson Nutritionals, Evansville, Indiana

William H. Johnston, MD

Birmingham Pediatric Group, Birmingham, Alabama

Suzanne I. Stolz

Mead Johnson Nutritionals, Evansville, Indiana

Cheryl L. Harris, MS

Mead Johnson Nutritionals, Evansville, Indiana

Susan Hazels Mitmesser, PhD

Mead Johnson Nutritionals, Evansville, Indiana, susan.mitmesser{at}bms.com

Very fussy or extremely fussy infants were randomized to receive: soy-based formula (Soy: n = 82) or a partially hydrolyzed cow's milk protein (CMP), low-lactose formula (PHF: n = 77) in a multicenter, double-blind, randomized, parallel, prospective 28-day feeding trial. Body weight and infant formula tolerance were reported. Adverse events were recorded throughout the study. A significant reduction in mean scores of fussiness, gas, spit-up, and crying compared with baseline measures was observed in infants who received either Soy or PHF within 1 day of formula intake; improvement in symptoms was sustained by study end. Stool consistency remained constant through day 28 in the PHF group, whereas stools in the Soy group became more firm by day 2 and did not return to prestudy consistency. PHF, with a protein profile patterned more closely on human breast milk, improved symptoms of formula intolerance as well as soy-based formula.

Key Words: infant formula • partially hydrolyzed formula • tolerance • fussy infants

This version was published on January 1, 2009

Clinical Pediatrics, Vol. 48, No. 1, 58-65 (2009)
DOI: 10.1177/0009922808321897
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