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| Name | Class |
|---|---|
| Charite University, Berlin, Germany | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control formula group | Active Comparator | infants are fed a commercial, hydrolysed formula during the first 4 month of life, according to protocol |
|
| intervention formula 1 group | Experimental | infants are fed hydrolyzed infant formula with different protein content during the first 4 month of life, according to protocol |
|
| intervention formula 2 group | Experimental | infants are fed hydrolyzed infant formula with different protein content with pro- and prebiotics during the first 4 month of life, according to protocol |
|
| intervention formula 3 group | Experimental | infants are fed hydrolyzed instant formula with different protein content with pro- and prebiotics during the first 4 months of life, according to protocol |
|
| Reference group | No Intervention | infants are breast fed |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| control formula | Other | infants are fed a commercial hydrolyzed formula |
| |
| Measure | Description | Time Frame |
|---|---|---|
| average weight gain | The intervention is to assess average weight gain in the first 4 months of life. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| allergic sensitization and symptoms | blood sample to assess allergic predisposition | 12 months |
| Anthropometric data at age of 4 years | Weight, length and Head circumference measurements at Age of 4 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ulrich Wahn, Prof. | Charité - Universitätsmedizin. Campus Virchow-Klinikum. Klinik für Pädiatrie mit Schwerpunkt Pneumologie/Immunologie | Principal Investigator |
| Kirsten Beyer, Prof | Charité - Universitätsmedizin. Campus Virchow-Klinikum. Klinik für Pädiatrie mit Schwerpunkt Pneumologie/Immunologie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinik für Kinder- und Jugendheilkunde, Abt. Neonatologie, päd. Intensivmedizin und Neuropädiatrie | Vienna | 1090 | Austria | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29216020 | Derived | Ahrens B, Hellmuth C, Haiden N, Olbertz D, Hamelmann E, Vusurovic M, Fleddermann M, Roehle R, Knoll A, Koletzko B, Wahn U, Beyer K. Hydrolyzed Formula With Reduced Protein Content Supports Adequate Growth: A Randomized Controlled Noninferiority Trial. J Pediatr Gastroenterol Nutr. 2018 May;66(5):822-830. doi: 10.1097/MPG.0000000000001853. |
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| intervention formula 1 |
| Other |
formula has hydrolysed protein and a different protein content |
|
| intervention formula 2 | Other | formula has hydrolysed protein, different protein content and pro- and prebiotics |
|
| intervention formula 3 | Other | formula has hydrolysed protein, different protein content and pro- and prebiotics |
|
| 4 years |
| Body composition (Skin fold) at age of 4 years | Caliper measurement at Age of 4 years | 4 years |
| Body composition (fat mass, lean body mass) at age of 4 years | bioelectrical impedance Analysis at Age of 4 years | 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 | 4 years |
| University Hospital Rostock |
| Rostock |
| Mecklenburg-Vorpommern |
| 18059 |
| Germany |
| Klinik für Kinder- und Jugendmedizin der Ruhr-Universität Bochum | Bochum | North Rhine-Westphalia | 44791 | Germany |
| Charité - Universitätsmedizin. Campus Virchow-Klinikum. Klinik für Pädiatrie mit Schwerpunkt Pneumologie/Immunologie | Berlin | 13353 | Germany |
| KBC "Dr Dragiša Mišović Dedinje" | Belgrade | 11000 | Serbia |