Infant Development, Protein Deposition, Protein-energy; Imbalance
Conditions
Keywords
protein turnover, growth, tracer, macronutrients
Brief summary
The purpose of this study is to measure protein turnover rates in preterm infants.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTMacronutrients_CARB
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
DIETARY_SUPPLEMENTMacronutrient_FAT
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
Sponsors
University Medical Center Rostock
Klinikum Südstadt, Rostock, Germany
Paracelsus Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Doctors, nurses and parents are blinded to the intervention
Eligibility
Sex/Gender
MALE
Age
23 Weeks to 32 Weeks
Healthy volunteers
No
Inclusion criteria
* Gestational age \< 32 weeks * Enteral nutrition \>150 mL / kg / d
Exclusion criteria
* gastrointestinal malformations * Enterostoma * short bowel syndrome * necrotizing enterocolitis * kidney disease * Foreseeable transfer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| weight gain | daily for 3 weeks | weight gain in gram |
| Protein turnover and net protein gain | weekly for 3 weeks | Tracer N15 labelled amino acids |
| Protein excretion | weekly for 3 weeks | Urinary urea in mg/dL and urine volume in mL will be combined to report protein excretion per urine sample (g/kg/d). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nutritional intake | daily for 3 weeks | 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 |
| body composition | weekly for 3 weeks | Fat mass in g, fat-free mass g, volume in L will be combined to report body density in kg/L |
| head circumference | daily for 3 weeks | in cm |
| body length | daily for 3 weeks | in cm |
Countries
Germany
Contacts
Primary ContactChristoph Fusch, Prof. Dr. med.
Backup ContactNiels Rochow, PD Dr. med.
Outcome results
None listed