Protein Turnover in Preterm Infants - Feeding of Target Fortified Breast Milk With Different Carbohydrate and Fat Composition to Improve Growth
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 3
- Primary Endpoint
- weight gain
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Doctors, nurses and parents are blinded to the intervention
Eligibility Criteria
- Ages
- 23 Weeks to 32 Weeks (Child)
- Sex
- Male
- Accepts 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
Arms & Interventions
Macronutrient_CARB
High carbs, low fat composition.
Intervention: Macronutrients_CARB (Dietary Supplement)
Macronutrient_FAT
Low carbs, high fat composition.
Intervention: Macronutrient_FAT (Dietary Supplement)
Outcomes
Primary Outcomes
weight gain
Time Frame: daily for 3 weeks
weight gain in gram
Protein turnover and net protein gain
Time Frame: weekly for 3 weeks
Tracer N15 labelled amino acids
Protein excretion
Time Frame: 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 Outcomes
- Nutritional intake(daily for 3 weeks)
- head circumference(daily for 3 weeks)
- body length(daily for 3 weeks)
- body composition(weekly for 3 weeks)
Investigators
Niels Rochow, MD, PhD
Principal Investigator
Paracelsus Medical University