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

Infant Development Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04854226
• Other study ID #: SZ_D_069_20-IX-1
• Status: Recruiting
• Phase: N/A
• Start date: April 21, 2021
• Est. completion date: August 31, 2024

Study information

• Verified date: February 2023
• Source: Paracelsus Medical University
• Contact: Christoph Fusch, Prof. Dr. med.
• Phone: +49911 398-2307
• Email: christoph.fusch[@]klinikum-nuernberg.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 23 Weeks to 32 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Infant Development
• Protein Deposition
• Protein-energy; Imbalance

Intervention

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
• 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

Locations

Country	Name	City	State
Germany	Klinik für Neugeborene, Kinder und Jugendliche Universitätsklinik der Paracelsus Medizinischen Privatuniversität	Nürnberg
Germany	Klinikum Südstadt Rostock Abteilung für Neonatologie und Neonatologische Intensivmedizin	Rostock
Germany	Universitätsmedizin Rostock Kinder und Jugendklinik	Rostock

Sponsors (3)

Lead Sponsor	Collaborator
Paracelsus Medical University	Klinikum Südstadt, Rostock, Germany, University Medical Center Rostock

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight gain	weight gain in gram	daily for 3 weeks
Primary	Protein turnover and net protein gain	Tracer N15 labelled amino acids	weekly for 3 weeks
Primary	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	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
Secondary	head circumference	in cm	daily for 3 weeks
Secondary	body length	in cm	daily for 3 weeks
Secondary	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