Infant DevelopmentNCT04854226
Protein Turnover in Preterm Infants - Feeding of Target Fortified Breast Milk With Different Macronutrient Composition to Improve Growth
A study testing Macronutrients_CARB and Macronutrient_FAT in people with Infant Development and Protein-energy; Imbalance, run by Paracelsus Medical University at 3 sites in Germany.
Trial summary
The purpose of this study is to measure protein turnover rates in preterm infants. Read more about this study
- Who is it for?
- Ages 23 to 32 weeks, men only
- Conditions the study is for
- Infant Development, Protein-energy; Imbalance, Protein Deposition
- What is being tested?
- Macronutrients_CARB and Macronutrient_FAT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesGermany
- Study dates
- 21 Apr 2021to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 32 weeks
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Gestational age < 32 weeks
- Enteral nutrition >150 mL / kg / d
Who cannot join
- gastrointestinal malformations
- Enterostoma
- short bowel syndrome
- necrotizing enterocolitis
- kidney disease
- Foreseeable transfer
Trial locations and contacts
3 sites in 1 country.
Germany3 sites, 3 recruiting
- Recruiting
Klinik für Neugeborene, Kinder und Jugendliche Universitätsklinik der Paracelsus Medizinischen Privatuniversität
Nuremberg, 90471
Christoph Fusch, Prof. Dr. med., +49911398-2307, christoph.fusch@klinikum-nuernberg.de
Niels Rochow, PD Dr. med., +49911398-118903, Niels.Rochow@klinikum-nuernberg.de
- Not yet recruiting
Universitätsmedizin Rostock Kinder und Jugendklinik
Rostock, 18057
Jan Däbritz, Prof. Dr. med., +49381-494 7001, jan.daebritz@med.uni-rostock.de
Klaus Wutzke, Prof., klaus-dieter.wutzke@uni-rostock.de
- Not yet recruiting
Klinikum Südstadt Rostock Abteilung für Neonatologie und Neonatologische Intensivmedizin
Rostock, 18059
Dirk Manfred Olbertz, PD Dr . med., +49381 4401 ext. 5500, dirk.olbertz@kliniksued-rostock.de
About this study
Official title: 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.
Read the 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.
- Being tested
- Macronutrients_CARB, Macronutrient_FAT
- Keywords
- protein turnover, growth, tracer, macronutrients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Macronutrients_CARBDietary 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_FATDietary 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
| Study group | Role | What they receive |
|---|---|---|
| Macronutrient_CARB | Experimental | High carbs, low fat composition. Receives: Dietary Supplement: Macronutrients_CARB |
| Macronutrient_FAT | Active comparator | Low carbs, high fat composition. Receives: Dietary Supplement: Macronutrient_FAT |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight gain
weight gain in gram
Measured: daily for 3 weeks
Protein turnover and net protein gain
Tracer N15 labelled amino acids
Measured: 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).
Measured: weekly for 3 weeks
Secondary outcomes (4)
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
Measured: daily for 3 weeks
head circumference
in cm
Measured: daily for 3 weeks
body length
in cm
Measured: 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
Measured: weekly for 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start21 Apr 2021
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paracelsus Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Center Rostock, Klinikum Südstadt, Rostock, Germany
- Responsible party
- Principal investigator, Niels Rochow, MD, PhD, Paracelsus Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04854226
- Sponsor's protocol ID
- SZ_D_069_20-IX-1
- Status last verified
- Feb 2023
- First submitted
- 12 Apr 2021
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protein Turnover in Preterm Infants - Feeding of Target Fortified Breast Milk With Different Carbohydrate and Fat Composition to Improve Growth
- ClinicalTrials.gov ID
- NCT04854226
- Acronym / sponsor ID
- SZ_D_069_20-IX-1
- Keywords
- protein turnover, growth, tracer, macronutrients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Paracelsus Medical UniversityUniversity, hospital or other
- Collaborators
- University Medical Center Rostock, Klinikum Südstadt, Rostock, Germany
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 22 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to measure protein turnover rates in preterm infants.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Macronutrient_CARB | Experimental | Dietary Supplement: Macronutrients_CARBHigh carbs, low fat composition. |
| Macronutrient_FAT | Active comparator | Dietary Supplement: Macronutrient_FATLow carbs, high fat composition. |
Who may qualify
- Ages
- 23 to 32 weeks
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Gestational age < 32 weeks
- Enteral nutrition >150 mL / kg / d
Key exclusion criteria (6 listed)
- gastrointestinal malformations
- Enterostoma
- short bowel syndrome
- necrotizing enterocolitis
- kidney disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Macronutrients_CARBBreast 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 | Dietary supplement | Macronutrient_CARB |
| Macronutrient_FATBreast 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 | Dietary supplement | Macronutrient_FAT |
Primary outcome
weight gain
Time frame: daily for 3 weeks
weight gain in gram
Protein turnover and net protein gain
Time frame: weekly for 3 weeks
Tracer N15 labelled amino acids
Protein excretion
Time frame: 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).
4 secondary outcomes
Nutritional intake
Time frame: daily for 3 weeks
head circumference
Time frame: daily for 3 weeks
body length
Time frame: daily for 3 weeks
body composition
Time frame: weekly for 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Macronutrients_CARB and Macronutrient_FAT in people with Infant Development and Protein-energy; Imbalance, run by Paracelsus Medical University at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christoph Fusch, Prof. Dr. med. (+49911 398-2307, christoph.fusch@klinikum-nuernberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight gain (time frame: daily for 3 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2023.