The study is conducted to examine the suitability of partially respectively extensively hydrolyzed low protein infant formulae with and without pro- and prebiotics for healthy, term infants. Primary hypothesis to be tested is: an infant formula based on a Protein hydrolysate with modified protein content is non inferior compared to a standard infant formula based on a Protein hyrolysate in respect to proper growth of healthy, term infants within the first four month of life. 4-year follow-up (without further Intervention) will focus on body composition and allergic predisposition.
View Section Brief Summary
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
503
infants are fed a commercial hydrolyzed formula
formula has hydrolysed protein and a different protein content
formula has hydrolysed protein, different protein content and pro- and prebiotics
formula has hydrolysed protein, different protein content and pro- and prebiotics
Universitätsklinik für Kinder- und Jugendheilkunde, Abt. Neonatologie, päd. Intensivmedizin und Neuropädiatrie
Vienna, Austria
University Hospital Rostock
Rostock, Mecklenburg-Vorpommern, Germany
Klinik für Kinder- und Jugendmedizin der Ruhr-Universität Bochum
Bochum, North Rhine-Westphalia, Germany
Charité - Universitätsmedizin. Campus Virchow-Klinikum. Klinik für Pädiatrie mit Schwerpunkt Pneumologie/Immunologie
Berlin, Germany
KBC "Dr Dragiša Mišović Dedinje"
Belgrade, Serbia
average weight gain
The intervention is to assess average weight gain in the first 4 months of life.
Time frame: 4 months
allergic sensitization and symptoms
blood sample to assess allergic predisposition
Time frame: 12 months
Anthropometric data at age of 4 years
Weight, length and Head circumference measurements at Age of 4 years
Time frame: 4 years
Body composition (Skin fold) at age of 4 years
Caliper measurement at Age of 4 years
Time frame: 4 years
Body composition (fat mass, lean body mass) at age of 4 years
bioelectrical impedance Analysis at Age of 4 years
Time frame: 4 years
Allergic predisposition at age of 4 years by measuring specific IgE in blood
blood sample to allergic predisposition at Age of 4 years
Time frame: 4 years
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