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

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-21

Study Completion Date

2024-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Infant Development Protein-energy; Imbalance Protein Deposition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Doctors, nurses and parents are blinded to the intervention

Study Groups

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Macronutrient_CARB

High carbs, low fat composition.

Group Type EXPERIMENTAL

Macronutrients_CARB

Intervention Type DIETARY_SUPPLEMENT

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.

Group Type ACTIVE_COMPARATOR

Macronutrient_FAT

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

23 Weeks

Maximum Eligible Age

32 Weeks

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University Medical Center Rostock

OTHER

Sponsor Role collaborator

Klinikum Südstadt, Rostock, Germany

UNKNOWN

Sponsor Role collaborator

Paracelsus Medical University

OTHER

Sponsor Role lead

Responsible Party

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Niels Rochow, MD, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Klinik für Neugeborene, Kinder und Jugendliche Universitätsklinik der Paracelsus Medizinischen Privatuniversität

Nuremberg, , Germany

Site Status RECRUITING

Universitätsmedizin Rostock Kinder und Jugendklinik

Rostock, , Germany

Site Status NOT_YET_RECRUITING

Klinikum Südstadt Rostock Abteilung für Neonatologie und Neonatologische Intensivmedizin

Rostock, , Germany

Site Status NOT_YET_RECRUITING

Countries

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Germany

Central Contacts

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Christoph Fusch, Prof. Dr. med.

Role: CONTACT

+49911 398-2307

Niels Rochow, PD Dr. med.

Role: CONTACT

+49911-398-118903

Facility Contacts

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Christoph Fusch, Prof. Dr. med.

Role: primary

+49911398-2307

Niels Rochow, PD Dr. med.

Role: backup

+49911398-118903

Jan Däbritz, Prof. Dr. med.

Role: primary

+49381-494 7001

Klaus Wutzke, Prof.

Role: backup

Dirk Manfred Olbertz, PD Dr . med.

Role: primary

+49381 4401 ext. 5500

Other Identifiers

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SZ_D_069_20-IX-1

Identifier Type: -

Identifier Source: org_study_id

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