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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
40
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
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
Klinik für Neugeborene, Kinder und Jugendliche Universitätsklinik der Paracelsus Medizinischen Privatuniversität
Nuremberg, Germany
RECRUITINGUniversitätsmedizin Rostock Kinder und Jugendklinik
Rostock, Germany
NOT_YET_RECRUITINGKlinikum Südstadt Rostock Abteilung für Neonatologie und Neonatologische Intensivmedizin
Rostock, Germany
weight gain
weight gain in gram
Time frame: daily for 3 weeks
Protein turnover and net protein gain
Tracer N15 labelled amino acids
Time frame: 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).
Time frame: weekly for 3 weeks
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
Time frame: daily for 3 weeks
head circumference
in cm
Time frame: daily for 3 weeks
body length
in cm
Time frame: 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
Time frame: weekly for 3 weeks
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