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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Weight gain | From birth - to the end of study intervention (anticipated to be on average 1 week before discharge home at approx 37 weeks PMA) |
| Measure | Description | Time Frame |
|---|---|---|
| Head circumference growth | From birth - to the end of study intervention (anticipated to be on average 1 week before discharge home at approx 37 weeks PMA) |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma amino acid profile | at 2 and 4 weeks after start of intervention |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Axel Franz, MD | Universität Tübingen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Children's Hospital Tuebingen | Tübingen | 72076 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27893064 | Result | 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. | |
| 29739389 | Derived | 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. |
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| ID | Term |
|---|---|
| D011506 | Proteins |
| ID | Term |
|---|---|
| D000602 | Amino Acids, Peptides, and Proteins |
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| 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 Supplementation | Dietary Supplement | Protein supplementation independent of individual breast milk content using a standard-dose-protein breast milk fortifier until 1 week before discharge |
|
| 27164830 | Derived | 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. |