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

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

Study Overview

• Status: Recruiting
• Conditions: Infant Development; Protein-energy; Imbalance; Protein Deposition
• Intervention / Treatment: Dietary supplement: Macronutrients_CARB; Dietary supplement: Macronutrient_FAT

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christoph Fusch, Prof. Dr. med.; Phone Number: +49911 398-2307; Email: christoph.fusch@klinikum-nuernberg.de
• Study Contact Backup: Name: Niels Rochow, PD Dr. med.; Phone Number: +49911-398-118903; Email: Niels.Rochow@klinikum-nuernberg.de

Study Locations

• Germany
  • Nürnberg, Germany, 90471
    • Recruiting
    • Klinik für Neugeborene, Kinder und Jugendliche Universitätsklinik der Paracelsus Medizinischen Privatuniversität
    • Contact: Christoph Fusch, Prof. Dr. med.; Phone Number: +49911398-2307; Email: christoph.fusch@klinikum-nuernberg.de
    • Contact: Niels Rochow, PD Dr. med.; Phone Number: +49911398-118903; Email: Niels.Rochow@klinikum-nuernberg.de
  • Rostock, Germany, 18057
    • Not yet recruiting
    • Universitätsmedizin Rostock Kinder und Jugendklinik
    • Contact: Jan Däbritz, Prof. Dr. med.; Phone Number: +49381-494 7001; Email: jan.daebritz@med.uni-rostock.de
    • Contact: Klaus Wutzke, Prof.; Email: klaus-dieter.wutzke@uni-rostock.de
  • Rostock, Germany, 18059
    • Not yet recruiting
    • Klinikum Südstadt Rostock Abteilung für Neonatologie und Neonatologische Intensivmedizin
    • Contact: Dirk Manfred Olbertz, PD Dr . med.; Phone Number: 5500 +49381 4401; Email: dirk.olbertz@kliniksued-rostock.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 7 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Macronutrient_CARB; High carbs, low fat composition.	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
Active Comparator: Macronutrient_FAT; Low carbs, high fat composition.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutritional intake	Volume of Breast Milk in mL/kg/d, Lactose in g/100mL, protein g/100mL, fat g/100mL will be combinded to report energy in kcal/kg/d	daily for 3 weeks
head circumference	in cm	daily for 3 weeks
body length	in cm	daily for 3 weeks
body composition	Fat mass in g, fat-free mass g, volume in L will be combined to report body density in kg/L	weekly for 3 weeks

Collaborators and Investigators

• Sponsor: Paracelsus Medical University
• Collaborators: University Medical Center Rostock; Klinikum Südstadt, Rostock, Germany

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2021
• Primary Completion (Anticipated): August 31, 2024
• Study Completion (Anticipated): August 31, 2024

Study Registration Dates

• First Submitted: April 12, 2021
• First Submitted That Met QC Criteria: April 16, 2021
• First Posted (Actual): April 22, 2021

Study Record Updates

• Last Update Posted (Estimate): February 28, 2023
• Last Update Submitted That Met QC Criteria: February 27, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: tracer; growth; protein turnover; macronutrients
• Other Study ID Numbers: SZ_D_069_20-IX-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No