Tolerance of a standard intact protein formula versus a partially hydrolyzed formula in healthy, term infants

Carol Lynn Berseth,Jon Vanderhoof,Susan Hazels Mitmesser,John D Marunycz,Ekhard E Ziegler

doi:10.1186/1475-2891-8-27

Abstract

BackgroundParents who perceive common infant behaviors as formula intolerance-related often switch formulas without consulting a health professional. Up to one-half of formula-fed infants experience a formula change during the first six months of life.MethodsThe objective of this study was to assess discontinuance due to study physician-assessed formula intolerance in healthy, term infants. Infants (335) were randomized to receive either a standard intact cow milk protein formula (INTACT) or a partially hydrolyzed cow milk protein formula (PH) in a 60 day non-inferiority trial. Discontinuance due to study physician-assessed formula intolerance was the primary outcome. Secondary outcomes included number of infants who discontinued for any reason, including parent-assessed.ResultsFormula intolerance between groups (INTACT, 12.3% vs. PH, 13.7%) was similar for infants who completed the study or discontinued due to study physician-assessed formula intolerance. Overall study discontinuance based on parent- vs. study physician-assessed intolerance for all infants (14.4 vs.11.1%) was significantly different (P = 0.001).ConclusionThis study demonstrated no difference in infant tolerance of intact vs. partially hydrolyzed cow milk protein formulas for healthy, term infants over a 60-day feeding trial, suggesting nonstandard partially hydrolyzed formulas are not necessary as a first-choice for healthy infants. Parents frequently perceived infant behavior as formula intolerance, paralleling previous reports of unnecessary formula changes.Trial Registrationclinicaltrials.gov: NCT00666120

Highlights

Parents who perceive common infant behaviors as formula intolerance-related often switch formulas without consulting a health professional
A total of 335 healthy, term infants were randomized to receive one of two study formulas: a full lactose, intact cow milk protein (60:40 whey:casein) formula supplemented with docosahexaenoic acid (DHA) and arachidonic acid (ARA) (INTACT; Enfamil® LIPIL®, Mead Johnson Nutrition, Evansville, IN) or a 70% lactose, partially hydrolyzed cow milk protein (100:0 whey:casein) formula supplemented with DHA and ARA (PH; Good Start® Supreme, Nestlé® S.A., Vevey, Switzerland) over a 60 day period
A total of 335 infants enrolled at 17 study sites between June 2005 and February 2006 (INTACT, 167; partially hydrolyzed cow milk protein formula (PH), 168); two withdrew prior to receiving any study formula (Fig. 1)

Summary

Introduction

Parents who perceive common infant behaviors as formula intolerance-related often switch formulas without consulting a health professional. Breastfeeding is the ideal source of nutrition for infants, but standard cow milk-based formulas (CMBF) are an appropriate source of nutrition for most infants who are not breastfed [1] Some nonstandard formulas, such as soy-based or partially or extensively hydrolyzed protein cow milk-based formulas (CMBF), may be indicated for select groups of infants [2,3,4]. Published estimates of formula intolerance range from 2 to 15% [8,9], one-third to one-half of infants, undergo formula change during the first 6 months of life [5,6], implying unnecessary switching or use of nonstandard formulas in healthy term infants. Parents or caregivers made 47% to 96% of decisions to discontinue a formula based most often on misinterpretation of common infantile behavior patterns as formula intolerance-related [5,6]

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