Protein Turnover in Preterm Infants - Feeding of Target Fortified Breast Milk With Different Macronutrient Composition to Improve Growth
1 other identifier
interventional
40
1 country
3
Brief Summary
The purpose of this study is to measure protein turnover rates in preterm infants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2021
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2021
CompletedStudy Start
First participant enrolled
April 21, 2021
CompletedFirst Posted
Study publicly available on registry
April 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2024
CompletedFebruary 28, 2023
February 1, 2023
3.4 years
April 12, 2021
February 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (4)
Nutritional intake
daily for 3 weeks
head circumference
daily for 3 weeks
body length
daily for 3 weeks
body composition
weekly for 3 weeks
Study Arms (2)
Macronutrient_CARB
EXPERIMENTALHigh carbs, low fat composition.
Macronutrient_FAT
ACTIVE COMPARATORLow carbs, high fat composition.
Interventions
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
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
You may qualify if:
- Gestational age \< 32 weeks
- Enteral nutrition \>150 mL / kg / d
You may not qualify if:
- gastrointestinal malformations
- Enterostoma
- short bowel syndrome
- necrotizing enterocolitis
- kidney disease
- Foreseeable transfer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Paracelsus Medical Universitylead
- University Medical Center Rostockcollaborator
- Klinikum Südstadt, Rostock, Germanycollaborator
Study Sites (3)
Klinik für Neugeborene, Kinder und Jugendliche Universitätsklinik der Paracelsus Medizinischen Privatuniversität
Nuremberg, 90471, Germany
Universitätsmedizin Rostock Kinder und Jugendklinik
Rostock, 18057, Germany
Klinikum Südstadt Rostock Abteilung für Neonatologie und Neonatologische Intensivmedizin
Rostock, 18059, Germany
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Doctors, nurses and parents are blinded to the intervention
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 12, 2021
First Posted
April 22, 2021
Study Start
April 21, 2021
Primary Completion
August 31, 2024
Study Completion
August 31, 2024
Last Updated
February 28, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share