title: Allergies in high-risk schoolchildren after early intervention with cow's milk protein hydrolysates: 10-year results from the German Infant Nutritional Intervention (GINI) study.
abstract: BACKGROUND
  The long-term effect of nutritional intervention with hydrolysate infant formulas on allergic manifestations in high-risk children is uncertain.
  
  
  OBJECTIVE
  We sought to investigate the effect of hydrolysate infant formulas on allergic phenotypes in children with family history of allergies at school age.
  
  
  METHODS
  We analyzed data from participants of the prospective German Infant Nutritional Intervention study after 10 years of follow-up. At birth, children were randomly assigned to receive, for the first 4 months, one of 4 blinded formulas as breast milk substitute, if necessary: partially hydrolyzed whey formula (pHF-W), extensively hydrolyzed whey formula (eHF-W), extensively hydrolyzed casein formula (eHF-C), or standard cow's milk formula. Outcomes were parent-reported, physician-diagnosed allergic diseases. Log-binomial regression models were used for statistical analysis.
  
  
  RESULTS
  The relative risk for the cumulative incidence of any allergic disease in the intention-to-treat analysis (n = 2252) was 0.87 (95% CI, 0.77-0.99) for pHF-W, 0.94 (95% CI, 0.83-1.07) for eHF-W, and 0.83 (95% CI, 0.72-0.95) for eHF-C compared with standard cow's milk formula. The corresponding figures for atopic eczema/dermatits (AD) were 0.82 (95% CI, 0.68-1.00), 0.91 (95% CI, 0.76-1.10), and 0.72 (95% CI, 0.58-0.88), respectively. In the per-protocol analysis (n = 988) effects were stronger. The period prevalence of AD at 7 to 10 years was significantly reduced with eHF-C in this analysis, but there was no preventive effect on asthma or allergic rhinitis.
  
  
  CONCLUSIONS
  The significant preventive effect on the cumulative incidence of allergic diseases, particularly AD, with pHF-W and eHF-C persisted until 10 years without rebound, whereas eHF-W showed no significant risk reduction. There is insufficient evidence of ongoing preventive activity at 7 to 10 years of age.
authors.affiliation: Marien-Hospital Wesel, Research Institute, Department of Pediatrics, Wesel, Germany. andrea.vonberg@prohomine.de
authors.forename: Andrea
authors.initials: A
authors.lastname: von Berg
authors.forename: Birgit
authors.initials: B
authors.lastname: Filipiak-Pittroff
authors.forename: Ursula
authors.initials: U
authors.lastname: Krämer
authors.forename: Barbara
authors.initials: B
authors.lastname: Hoffmann
authors.forename: Elke
authors.initials: E
authors.lastname: Link
authors.forename: Christina
authors.initials: C
authors.lastname: Beckmann
authors.forename: Ute
authors.initials: U
authors.lastname: Hoffmann
authors.forename: Dietrich
authors.initials: D
authors.lastname: Reinhardt
authors.forename: Armin
authors.initials: A
authors.lastname: Grübl
authors.forename: Joachim
authors.initials: J
authors.lastname: Heinrich
authors.forename: H-Erich
authors.initials: HE
authors.lastname: Wichmann
authors.forename: Carl-P
authors.initials: CP
authors.lastname: Bauer
authors.forename: Sibylle
authors.initials: S
authors.lastname: Koletzko
authors.forename: Dietrich
authors.initials: D
authors.lastname: Berdel
mesh_terms: D000818:Animals; D002417:Cattle; D002648:Child; D002675:Child, Preschool; D061345:Early Medical Intervention; D005500:Follow-Up Studies; D006801:Humans; D006967:Hypersensitivity / Q000453:epidemiology* / Q000517:prevention & control*; D015994:Incidence; D007223:Infant; D007231:Infant, Newborn; D008894:Milk Proteins / Q000008:administration & dosage / Q000276:immunology*; D017063:Outcome Assessment, Health Care; D015995:Prevalence
chemical_list: D008894:Milk Proteins