title: Long-term effects of hydrolyzed protein infant formulas on growth--extended follow-up to 10 y of age: results from the German Infant Nutritional Intervention (GINI) study.
abstract: BACKGROUND
  Previous analysis in a prospective, population-based cohort reported reduced weight gain in children fed extensively hydrolyzed casein (eHF-C) formula during the first year of life but showed no effect on growth between 1 and 6 y of life. No studies have been conducted in children up to the age of 10 y.
  
  
  OBJECTIVE
  The objective was to investigate potential differences in body mass index (BMI) over the first 10 y of life between infants fed within the intervention period of the first 16 wk of life with partially hydrolyzed whey (pHF-W), extensively hydrolyzed whey (eHF-W), eHF-C, or cow-milk formula (CMF) and infants exclusively breastfed (BF) within the intervention period.
  
  
  METHODS
  This was a prospective, randomized, double-blind trial in full-term neonates with atopic heredity in the German birth cohort German Infant Nutritional Intervention (GINI) followed through the first 10 y of life. Analyses of absolute and World Health Organization (WHO)-standardized BMI trajectories for 1840 infants [pHF-W (n = 253), eHF-W (n = 265), eHF-C (n = 250), CMF (n = 276), and BF (n = 796)] were conducted according to intention-to-treat principles.
  
  
  RESULTS
  Except for the previously reported slower BMI gain in infants fed with eHF-C formula within the first year of life, no significant differences in absolute or WHO-standardized BMI trajectories were shown between the pHF-W, eHF-W, eHF-C, CMF, and BF groups thereafter up to the age of 10 y.
  
  
  CONCLUSIONS
  Extension of the follow-up period from 6 to 10 y for this randomized controlled trial showed no long-term consequences on BMI for the 4 infant formulas considered. These data need to be confirmed in future studies.
authors.affiliation: From Helmholtz Zentrum München, German Research Center for Environmental Health, Institute of Epidemiology, Neuherberg, Germany, Ludwig-Maximilians-University of Munich, Munich, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Rzehak
authors.forename: Stefanie
authors.initials: S
authors.lastname: Sausenthaler
authors.forename: Sibylle
authors.initials: S
authors.lastname: Koletzko
authors.forename: Dietrich
authors.initials: D
authors.lastname: Reinhardt
authors.forename: Andrea
authors.initials: A
authors.lastname: von Berg
authors.forename: Ursula
authors.initials: U
authors.lastname: Krämer
authors.forename: Dietrich
authors.initials: D
authors.lastname: Berdel
authors.forename: Christina
authors.initials: C
authors.lastname: Bollrath
authors.forename: Armin
authors.initials: A
authors.lastname: Grübl
authors.forename: Carl P
authors.initials: CP
authors.lastname: Bauer
authors.forename: H-Erich
authors.initials: HE
authors.lastname: Wichmann
authors.forename: Joachim
authors.initials: J
authors.lastname: Heinrich
mesh_terms: D015992:Body Mass Index; D001942:Breast Feeding; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D047109:Fetal Development / Q000187:drug effects*; D005500:Follow-Up Studies; D005858:Germany; D006801:Humans; D006868:Hydrolysis; D007223:Infant; D041943:Infant Formula / Q000737:chemistry*; D008297:Male; D008894:Milk Proteins / Q000008:administration & dosage*; D011446:Prospective Studies; D013995:Time
chemical_list: D008894:Milk Proteins