NCT04854226

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Paracelsus Medical University · Academic / Other
• Sex: Male
• Age: 23 Weeks – 32 Weeks
• Healthy volunteers: Not accepted

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.

Conditions

• Infant Development
• Protein-energy; Imbalance
• Protein Deposition

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Macronutrients_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_SUPPLEMENT	Macronutrient_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

Timeline

• Start date: 2021-04-21
• Primary completion: 2024-08-31
• Completion: 2024-08-31
• First posted: 2021-04-22
• Last updated: 2023-02-28

Locations

3 sites across 1 country: Germany