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Randomized Controlled Trial
. 2009 Jun 19:8:27.
doi: 10.1186/1475-2891-8-27.

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

Carol Lynn Berseth  1 , Susan Hazels Mitmesser, Ekhard E Ziegler, John D Marunycz, Jon Vanderhoof
Affiliations
Randomized Controlled Trial

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

Carol Lynn Berseth et al. Nutr J. .

Abstract

Background: Parents 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.

Methods: The 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.

Results: Formula 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).

Conclusion: This 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 registration: clinicaltrials.gov: NCT00666120.

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Figures

Figure 1
Figure 1
Flow of study participants.
Figure 2
Figure 2
Percentage of infants that continued to consume INTACT formula (full line) or PH formula (dashed line) from enrollment (day 1 of study) to day 60.
See this image and copyright information in PMC

References

    1. Kleinman RE, ed . American Academy of Pediatrics. Pediatric nutrition handbook. 5. Elk Grove Village, IL: American Academy of Pediatrics; 2004.
    1. American Academy of Pediatrics. Committee on Nutrition. Soy protein-based formulas: recommendations for use in infant feeding. Pediatrics. 1998;101:148–153. - PubMed
    1. Maldonado J, Gil A, Narbona E, Molina JA. Special formulas in infant nutrition: a review. Early Hum Dev. 1998;53:S23–32. doi: 10.1016/S0378-3782(98)00062-0. - DOI - PubMed
    1. American Academy of Pediatrics. Committee on Nutrition. Hypoallergenic infant formulas. Pediatrics. 2000;106:346–349. - PubMed
    1. Nevo N, Rubin L, Tamir A, Levine A, Shaoul R. Infant feeding patterns in the first 6 months: an assessment in full-term infants. J Pediatr Gastroenterol Nutr. 2007;45:234–239. doi: 10.1097/MPG.0b013e31803e1706. - DOI - PubMed

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