Extreme PrematurityNCT01773902
Protein for Premies
A study testing High Dose Protein (Individualized), High Dose Protein (Standardized) and Standard Protein Supplementation in people with Extreme Prematurity, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Although expressed breast milk is considered the optimal nutritional source for preterm infants, the macronutrient content is insufficient to enable optimal growth during neonatal intensive care. Read more about this study
- Who is it for?
- Ages Up to 7 days
- Conditions the study is for
- Extreme Prematurity
- What is being tested?
- High Dose Protein (Individualized), High Dose Protein (Standardized) and Standard Protein Supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2012to Jul 2016
- 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 Up to 7 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- very preterm infants <32 weeks gestation and <1500g birth weight
- > 100ml/kg/d of enteral feeding
Who cannot join
- missing informed consent
- decision not to feed breast milk
- congenital malformations
- age > 7 days at study entry
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Versus Standard Dose Protein for Very Preterm Infants
Although expressed breast milk is considered the optimal nutritional source for preterm infants, the macronutrient content is insufficient to enable optimal growth during neonatal intensive care. Optimal dose and optimal mode of administration (standardized or individualized) of enteral protein supplementation to very preterm infants have not been established.
This study aims to compare the effects on weight gain of different modes of enteral protein supplementation.
- Conditions
- Extreme Prematurity
- Being tested
- High Dose Protein (Individualized), High Dose Protein (Standardized), Standard Protein Supplementation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Dose Protein (Individualized)Dietary supplement
Protein supplementation according to breast milk content aiming for 4.5g/kg/d of enteral protein if <1500g b.w. or 4.0g/kg/d of enteral protein if >1500g b.w. until 1 week before discharge
High Dose Protein (Standardized)Dietary supplement
Protein supplementation independent of individual breast milk content using a new high-dose-protein breast milk fortifier until 1 week before discharge
Standard Protein SupplementationDietary supplement
Protein supplementation independent of individual breast milk content using a standard-dose-protein breast milk fortifier until 1 week before discharge
| Study group | Role | What they receive |
|---|---|---|
| High Dose Protein (Individualized) | Experimental | Protein supplementation according to breast milk content aiming for 4.5g/kg/d of enteral protein if <1500g b.w. or 4.0g/kg/d of enteral protein if >1500g b.w. until 1 week before discharge Receives: Dietary Supplement: High Dose Protein (Individualized) |
| High Dose Protein (Standardized) | Experimental | Protein supplementation independent of individual breast milk content using a new high-dose-protein breast milk fortifier until 1 week before discharge Receives: Dietary Supplement: High Dose Protein (Standardized) |
| Standard protein supplementation | Active comparator | Protein supplementation independent of individual breast milk content using a standard dose of a standard breast milk fortifier until 1 week before discharge Receives: Dietary Supplement: Standard Protein Supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight gain
Measured: From birth - to the end of study intervention (anticipated to be on average 1 week before discharge home at approx 37 weeks PMA)
Secondary outcomes (1)
Head circumference growth
Measured: From birth - to the end of study intervention (anticipated to be on average 1 week before discharge home at approx 37 weeks PMA)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2013 (estimated)
- Study startOct 2012
- Primary completionDec 2014
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Extreme PrematurityStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Axel Franz, University Hospital Tuebingen
- Investigators
- Axel Franz, MD, Principal investigator, Universität Tübingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01773902
- Sponsor's protocol ID
- PfP3.2
- Status last verified
- May 2018
- First submitted
- 15 Jan 2013
- Last updated
- 15 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Maas C, Mathes M, Bleeker C, Vek J, Bernhard W, Wiechers C, Peter A, Poets CF, Franz AR. Effect of Increased Enteral Protein Intake on Growth in Human Milk-Fed Preterm Infants: A Randomized Clinical Trial. JAMA Pediatr. 2017 Jan 1;171(1):16-22. doi: 10.1001/jamapediatrics.2016.2681.
PubMed 27893064Mathes M, Maas C, Bleeker C, Vek J, Bernhard W, Peter A, Poets CF, Franz AR. Effect of increased enteral protein intake on plasma and urinary urea concentrations in preterm infants born at < 32 weeks gestation and < 1500 g birth weight enrolled in a randomized controlled trial - a secondary analysis. BMC Pediatr. 2018 May 8;18(1):154. doi: 10.1186/s12887-018-1136-5.
PubMed 29739389Maas C, Franz AR, Shunova A, Mathes M, Bleeker C, Poets CF, Schleicher E, Bernhard W. Choline and polyunsaturated fatty acids in preterm infants' maternal milk. Eur J Nutr. 2017 Jun;56(4):1733-1742. doi: 10.1007/s00394-016-1220-2. Epub 2016 May 10.
PubMed 27164830
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Versus Standard Dose Protein for Very Preterm Infants
- ClinicalTrials.gov ID
- NCT01773902
- Acronym / sponsor ID
- PfP3.2
- Conditions
- Extreme Prematurity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 23 Jan 2013 (estimated)
- 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.
Although expressed breast milk is considered the optimal nutritional source for preterm infants, the macronutrient content is insufficient to enable optimal growth during neonatal intensive care. Optimal dose and optimal mode of administration (standardized or individualized) of enteral protein supplementation to very preterm infants have not been established.
This study aims to compare the effects on weight gain of different modes of enteral protein supplementation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Dose Protein (Individualized) | Experimental | Dietary Supplement: High Dose Protein (Individualized)Protein supplementation according to breast milk content aiming for 4.5g/kg/d of enteral protein if <1500g b.w. or 4.0g/kg/d of enteral protein if >1500g b.w. until 1 week before discharge |
| High Dose Protein (Standardized) | Experimental | Dietary Supplement: High Dose Protein (Standardized)Protein supplementation independent of individual breast milk content using a new high-dose-protein breast milk fortifier until 1 week before discharge |
| Standard protein supplementation | Active comparator | Dietary Supplement: Standard Protein SupplementationProtein supplementation independent of individual breast milk content using a standard dose of a standard breast milk fortifier until 1 week before discharge |
Who may qualify
- Ages
- Up to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- very preterm infants <32 weeks gestation and <1500g birth weight
- > 100ml/kg/d of enteral feeding
Key exclusion criteria (4 listed)
- missing informed consent
- decision not to feed breast milk
- congenital malformations
- age > 7 days at study entry
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 |
|---|---|---|
| High Dose Protein (Individualized)Protein supplementation according to breast milk content aiming for 4.5g/kg/d of enteral protein if <1500g b.w. or 4.0g/kg/d of enteral protein if >1500g b.w. until 1 week before discharge | Dietary supplement | High Dose Protein (Individualized) |
| High Dose Protein (Standardized)Protein supplementation independent of individual breast milk content using a new high-dose-protein breast milk fortifier until 1 week before discharge | Dietary supplement | High Dose Protein (Standardized) |
| Standard Protein SupplementationProtein supplementation independent of individual breast milk content using a standard-dose-protein breast milk fortifier until 1 week before discharge | Dietary supplement | Standard protein supplementation |
Primary outcome
Weight gain
Time frame: From birth - to the end of study intervention (anticipated to be on average 1 week before discharge home at approx 37 weeks PMA)
1 secondary outcome
Head circumference growth
Time frame: From birth - to the end of study intervention (anticipated to be on average 1 week before discharge home at approx 37 weeks PMA)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2018.
- Results publication: PubMed 27893064Maas C, Mathes M, Bleeker C, Vek J, Bernhard W, Wiechers C, Peter A, Poets CF, Franz AR. Effect of Increased Enteral Protein Intake on Growth in Human Milk-Fed Preterm Infants: A Randomized Clinical Trial. JAMA Pediatr. 2017 Jan 1;171(1):16-22. doi: 10.1001/jamapediatrics.2016.2681.
- Derived from this study: PubMed 29739389Mathes M, Maas C, Bleeker C, Vek J, Bernhard W, Peter A, Poets CF, Franz AR. Effect of increased enteral protein intake on plasma and urinary urea concentrations in preterm infants born at < 32 weeks gestation and < 1500 g birth weight enrolled in a randomized controlled trial - a secondary analysis. BMC Pediatr. 2018 May 8;18(1):154. doi: 10.1186/s12887-018-1136-5.
- Derived from this study: PubMed 27164830Maas C, Franz AR, Shunova A, Mathes M, Bleeker C, Poets CF, Schleicher E, Bernhard W. Choline and polyunsaturated fatty acids in preterm infants' maternal milk. Eur J Nutr. 2017 Jun;56(4):1733-1742. doi: 10.1007/s00394-016-1220-2. Epub 2016 May 10.
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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.
Axel Franz, MD principal investigator
Universität Tübingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Dose Protein (Individualized), High Dose Protein (Standardized) and Standard Protein Supplementation in people with Extreme Prematurity, run by University Hospital Tuebingen at 1 site 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 4 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: finished, as of the sponsor's last update on 15 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight gain (time frame: From birth - to the end of study intervention (anticipated to be on average 1 week before discharge home at approx 37 weeks PMA)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01773902, which also lists 3 linked publications.
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 15 May 2018; AzTrials last refreshed its copy on 1 Nov 2026.