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

Paracelsus Medical University (PMU)

Status: Enrolling

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

Treatments: Dietary Supplement: Macronutrient_FAT; Dietary Supplement: Macronutrients_CARB

Study type: Interventional

Funder types: Other

Identifiers

NCT04854226

SZ_D_069_20-IX-1

Details and patient eligibility

About

The purpose of this study is to measure protein turnover rates in preterm infants.

Full 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.

Enrollment: 40 estimated patients

Sex: Male

Ages: 23 to 32 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

Macronutrient_CARB

Experimental group

Description:

High carbs, low fat composition.

Treatment:

Dietary Supplement: Macronutrients_CARB

Macronutrient_FAT

Active Comparator group

Description:

Low carbs, high fat composition.

Treatment:

Dietary Supplement: Macronutrient_FAT