Protein Turnover in Preterm Infants - Feeding of Target Fortified Breast Milk With Different Macronutrient Composition to Improve Growth
NCT ID: NCT04854226
Last Updated: 2023-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2021-04-21
2024-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Macronutrient_CARB
High carbs, low fat composition.
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
Macronutrient_FAT
Low carbs, high fat composition.
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
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
* Enteral nutrition \>150 mL / kg / d
Exclusion Criteria
* Enterostoma
* short bowel syndrome
* necrotizing enterocolitis
* kidney disease
* Foreseeable transfer
23 Weeks
32 Weeks
MALE
No
Sponsors
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University Medical Center Rostock
OTHER
Klinikum Südstadt, Rostock, Germany
UNKNOWN
Paracelsus Medical University
OTHER
Responsible Party
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Niels Rochow, MD, PhD
Principal Investigator
Locations
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Klinik für Neugeborene, Kinder und Jugendliche Universitätsklinik der Paracelsus Medizinischen Privatuniversität
Nuremberg, , Germany
Universitätsmedizin Rostock Kinder und Jugendklinik
Rostock, , Germany
Klinikum Südstadt Rostock Abteilung für Neonatologie und Neonatologische Intensivmedizin
Rostock, , Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SZ_D_069_20-IX-1
Identifier Type: -
Identifier Source: org_study_id
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