Study Results
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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COMPLETED
NA
60 participants
INTERVENTIONAL
2012-10-31
2016-07-31
Brief Summary
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This study aims to compare the effects on weight gain of different modes of enteral protein supplementation.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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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 (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)
Protein supplementation independent of individual breast milk content using a new high-dose-protein breast milk fortifier until 1 week before discharge
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
Protein supplementation independent of individual breast milk content using a standard dose of a standard breast milk fortifier until 1 week before discharge
Standard Protein Supplementation
Protein supplementation independent of individual breast milk content using a standard-dose-protein breast milk fortifier until 1 week before discharge
Interventions
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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)
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
Protein supplementation independent of individual breast milk content using a standard-dose-protein breast milk fortifier until 1 week before discharge
Eligibility Criteria
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Inclusion Criteria
* \> 100ml/kg/d of enteral feeding
Exclusion Criteria
* decision not to feed breast milk
* congenital malformations
* age \> 7 days at study entry
7 Days
ALL
No
Sponsors
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University Hospital Tuebingen
OTHER
Responsible Party
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Axel Franz
PD Dr. med.
Principal Investigators
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Axel Franz, MD
Role: PRINCIPAL_INVESTIGATOR
Universität Tübingen
Locations
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University Children's Hospital Tuebingen
Tübingen, , Germany
Countries
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References
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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.
Mathes 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.
Maas 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.
Other Identifiers
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PfP3.2
Identifier Type: -
Identifier Source: org_study_id
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