Atopic dermatitis and skin diseasePreventive effect of hydrolyzed infant formulas persists until age 6 years: Long-term results from the German Infant Nutritional Intervention Study (GINI)
Section snippets
Subjects
Between September 1995 and July 1998, healthy term newborns were recruited at birth in 2 regions of Germany (rural Wesel and urban Munich) for the GINI study birth cohort. The infants were enrolled before any formula supplementation had occurred and at the latest at 14 days of age. Detailed description of screening and recruitment has been provided elsewhere.22, 23 High-risk infants, defined as having at least 1 parent or sibling with a history of allergic diseases, were selected for the GINI
Study population and participation
The present analysis is based on the 2252 children primarily randomized to one of the 4 study formulas. The pattern concerning the beginning and duration of feeding with the study formula was equally distributed between the study formula groups. Only 139 (6%) infants were fed exclusively with study formula, whereas 889 (39.4%) of 2252 were exclusively breast-fed. During the strict intervention period (birth to 4 months of age), 988 children were compliant with the milk-feeding recommendation,
Discussion
The results of the GINI study with a follow-up until 6 years of age revealed the important finding that nutritional intervention with hydrolyzed infant formulas in the first 4 months of life has a long-lasting preventive effect on atopic eczema in high-risk children. The preventive effect of pHF-W and eHF-C on AM and AD found in the 2 previous analyses at age 1 year and until 3 years21, 22 could now be confirmed up to age 6 years in both the ITT and the PP analyses. Although we previously
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Cited by (0)
The German Infant Nutritional Intervention study was supported for the first 3 years by grants of the Federal Ministry for Education, Science, Research and Technology (Grant No. 01 EE 9401-4). The 6-year follow-up was partly funded by the Federal Ministry for Environment (IUF, FKZ 20462296) and by the GSF National Research Center for the Environment and Health.
Disclosure of potential conflict of interest: A. von Berg has served on the speakers' bureau for MSD, Nestlé, Novartis, and Aerocrine; has served as the principal investigator for Nestlé, Mead Johnson, GlaxoSmithKline, Aerocrine, Nycomed, MSD, Allergopharma, and ALK-Abelló; and has served as an expert witness for Aerocrine and Novartis. U. Krämer has received research support from the Deutsche gesetzliche Unfallversicherung and the Federal Ministry for Environment. E. Link has received research support from the Federal Ministry for Environment. S. Koletzko has received honoraria from Nestlé, Nutricia, and Hipp and has served as an investigator for Nestlé. D. Berdel has served on the speakers' bureau for MSD, Nestlé, and Wyeth. The rest of the authors have declared that they have no conflict of interest.