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

Sponsor

Paracelsus Medical University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04854226

Collaborator

University Medical Center Rostock (Other), Klinikum Südstadt, Rostock, Germany (Other)

Enrollment

Locations

Arms

22.5

Anticipated Duration (Months)

13.3

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Infant Development Protein-energy; Imbalance Protein Deposition	Dietary Supplement: Macronutrients_CARB Dietary Supplement: Macronutrient_FAT	N/A

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

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Doctors, nurses and parents are blinded to the intervention

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Apr 15, 2021

Anticipated Primary Completion Date :

Aug 31, 2022

Anticipated Study Completion Date :

Feb 28, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

weight gain [daily for 3 weeks]
weight gain in gram
Protein turnover and net protein gain [weekly for 3 weeks]
Tracer N15 labelled amino acids
Protein excretion [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 Outcome Measures

Nutritional intake [daily for 3 weeks]
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
head circumference [daily for 3 weeks]
in cm
body length [daily for 3 weeks]
in cm
body composition [weekly for 3 weeks]
Fat mass in g, fat-free mass g, volume in L will be combined to report body density in kg/L

Eligibility Criteria

Criteria

Ages Eligible for Study:

23 Weeks to 32 Weeks

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Klinik für Neugeborene, Kinder und Jugendliche Universitätsklinik der Paracelsus Medizinischen Privatuniversität	Nürnberg	Germany	90471
2	Universitätsmedizin Rostock Kinder und Jugendklinik	Rostock	Germany	18057
3	Klinikum Südstadt Rostock Abteilung für Neonatologie und Neonatologische Intensivmedizin	Rostock	Germany	18059

Sponsors and Collaborators

Paracelsus Medical University
University Medical Center Rostock
Klinikum Südstadt, Rostock, Germany

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Niels Rochow, MD, PhD, Principal Investigator, Paracelsus Medical University

ClinicalTrials.gov Identifier:

NCT04854226

Other Study ID Numbers:

SZ_D_069_20-IX-1

First Posted:

Apr 22, 2021

Last Update Posted:

Apr 22, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Niels Rochow, MD, PhD, Principal Investigator, Paracelsus Medical University

Study Results

No Results Posted as of Apr 22, 2021