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6 y of age: results from the German Infant Nutritional Intervention Study1,2,3
1 From the Helmholtz Zentrum München, German Research Center for Environmental Health, Institute of Epidemiology, Neuherberg, Germany (PR, SS, H-EW, and JH); Ludwig Maximilians University Munich, the Institute of Medical Data Management, Biometrics, and Epidemiology, Munich, Germany (PR and H-EW); Ludwig Maximilians University of Munich, Dr von Hauner Children's Hospital, Munich, Germany (SK and DR); the Department of Pediatrics, Marien Hospital Wesel, Wesel, Germany (AvB, DB, and CB); the Institut für Umweltmedizinische Forschung, University of Düsseldorf, Düsseldorf, Germany (UK); and Department of Pediatrics, Technical University of Munich, Munich, Germany (AvB and CPB).
2 Supported for 3 y by grants from the Federal Ministry for Education, Science, Research, and Technology (grant no. 01 EE 9401-4). The 6-y follow-up of the German Infant Nutritional Intervention-plus Study was partly funded by the Federal Ministry of Environment (Institut für Umweltmedizinische Forschung, grant no. FKZ 20462296). The analysis presented here has been partly conducted with financial support from the Nutricia Research Foundation (project no. 2007-12). Personal and financial support by the Munich Center of Health Sciences, which contributed to this research, is gratefully acknowledged.
3 Reprints not available. Address correspondence to P Rzehak, Helmholtz Zentrum München, German Research Center for Environmental Health. Institute of Epidemiology, Ingolstädter Landstrasse 1, D-85764 Neuherberg, Germany. E-mail: peter.rzehak{at}helmholtz-muenchen.de.
for the German Infant Nutritional Intervention Study Group
ABSTRACT
Background: The short- and long-term effects of feeding with hydrolyzed formulas on growth are uncertain.
Objective: Our aim was to investigate the potential differences in body mass index (BMI) over the first 6 y of life between infants fed by partially hydrolyzed whey (pHF-W), extensively hydrolyzed whey (eHF-W), extensively hydrolyzed casein (eHF-C), or cow-milk formula (CMF) and infants exclusively breastfed for the first 16 wk of life.
Design: We established a prospective, randomized, double-blind trial of full-term neonates with atopic heredity in the German birth cohort followed by the German Infant Nutritional Intervention Study through the first 6 y of life. Intention-to-treat and per-protocol analyses of absolute and World Health Organization–standardized BMI trajectories for 1840 infants (pHF-W: n = 253; eHF-W: n = 265; eHF-C: n = 250, CMF: n = 276; breastfed: n = 796) were performed.
Results: No significant differences in absolute or World Health Organization–standardized BMI trajectories were found among the pHF-W, eHF-W, CMF, and breastfed groups during the 6-y follow-up. However, in the eHF-C group, both intention-to-treat and per-protocol analyses showed a significantly slower sex-adjusted BMI gain through the 8th to 48th week of life (–0.1 to –0.2 lower BMI z score) but not beyond. Analyses of weight and length revealed that this difference is due to a slightly diminished weight gain in the first year of life because growth in length did not differ among study groups for the entire follow-up.
Conclusions: To our knowledge, this is the first randomized trial investigating both short- and long-term effects of partially and extensively hydrolyzed formula (pHF-W, eHF-W, eHF-C), CMF, and breastfeeding on growth in one trial. Feeding with eHF-C led to a transient lower weight gain in the first year of life. No long-term consequences of different formulas on BMI were observed.
Received for publication December 16, 2008. Accepted for publication March 7, 2009.
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