Protein Turnover in Preterm Infants - Feeding of Target Fortified Breast Milk With Different Macronutrient Composition to Improve Growth

Study Overview
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Brief Summary
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The purpose of this study is to measure protein turnover rates in preterm infants.

Detailed Description
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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.

Official Title
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Protein Turnover in Preterm Infants - Feeding of Target Fortified Breast Milk With Different Carbohydrate and Fat Composition to Improve Growth

Conditions
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Infant Development, Protein-energy; Imbalance, Protein Deposition

Intervention / Treatment
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* Dietary Supplement: Macronutrients_CARB
* Dietary Supplement: Macronutrient_FAT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 23 Weeks
Maximum Age: 32 Weeks

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Macronutrient_CARB<br>High carbs, low fat composition. | Dietary Supplement: Macronutrients_CARB<br>* 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<br>|
| Active Comparator: Macronutrient_FAT<br>Low carbs, high fat composition. | Dietary Supplement: Macronutrient_FAT<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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macronutrients, protein turnover, growth, tracer