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| Name | Class |
|---|---|
| University Medical Center Rostock | OTHER |
| Klinikum Südstadt, Rostock, Germany | UNKNOWN |
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The purpose of this study is to measure protein turnover rates in preterm infants.
After being informed about the study and potential risks, all parents giving written informed consent the principal investigator will determine the eligibility for study entry. Patients who met the eligibility requirements will be randomized in a double-blind manner in a 1:1 ratio to fortified breast milk with higher fat composition to fortified breast milk with higher carbohydrate composition. Both groups will receive a stable protein composition. The participants will receive the intervention for 3 consecutive weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Macronutrient_CARB | Experimental | High carbs, low fat composition. |
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| Macronutrient_FAT | Active Comparator | Low carbs, high fat composition. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Macronutrients_CARB | Dietary Supplement | Breast milk 150 to 170 mL/d; Target fortification: 9.0 g/100mL COH, 3.0 g/100mL protein, 4.0 g/100mL fat, 86.4 kcal/100mL |
|
| Measure | Description | Time Frame |
|---|---|---|
| weight gain | weight gain in gram | daily for 3 weeks |
| Protein turnover and net protein gain | Tracer N15 labelled amino acids | weekly for 3 weeks |
| Protein excretion | Urinary urea in mg/dL and urine volume in mL will be combined to report protein excretion per urine sample (g/kg/d). | weekly for 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Nutritional intake | Volume of Breast Milk in mL/kg/d, Lactose in g/100mL, protein g/100mL, fat g/100mL will be combinded to report energy in kcal/kg/d | daily for 3 weeks |
| head circumference | in cm |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christoph Fusch, Prof. Dr. med. | Contact | +49911 398-2307 | christoph.fusch@klinikum-nuernberg.de | |
| Niels Rochow, PD Dr. med. | Contact | +49911-398-118903 | Niels.Rochow@klinikum-nuernberg.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik für Neugeborene, Kinder und Jugendliche Universitätsklinik der Paracelsus Medizinischen Privatuniversität | Recruiting | Nuremberg | 90471 | Germany |
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Doctors, nurses and parents are blinded to the intervention
| Macronutrient_FAT | Dietary Supplement | Breast milk 150 to 170 mL/d; Target fortification: 5.5 g/100mL COH, 3.0 g/100mL protein, 5.5 g/100mL fat, 86 kcal/100mL |
|
| daily for 3 weeks |
| body length | in cm | daily for 3 weeks |
| body composition | Fat mass in g, fat-free mass g, volume in L will be combined to report body density in kg/L | weekly for 3 weeks |
| Universitätsmedizin Rostock Kinder und Jugendklinik | Not yet recruiting | Rostock | 18057 | Germany |
|
| Klinikum Südstadt Rostock Abteilung für Neonatologie und Neonatologische Intensivmedizin | Not yet recruiting | Rostock | 18059 | Germany |
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