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| Name | Class |
|---|---|
| Children's Health System, Alabama | OTHER |
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The study hypothesis is that, in human milk-fed extremely preterm infants, higher protein intake compared to usual protein intake reduces percent body fat (%BF) at 3 months of age.
Qualifying participants will be randomly assigned to receive either standard protein supplementation (control group) or high protein supplementation (intervention group).
Intervention group: A fixed amount of commercially available hydrolyzed bovine protein will be added to fortified human milk after establishment of full enteral feeding.
Control group: Hydrolyzed bovine protein will not be added to fortified human milk after establishment of full enteral feeding.
If parent agrees, stool "dirty" diapers will be collected 2 times (at the time of hospital discharge and at 3 months of corrected age).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High protein supplementation | Experimental | Infants will receive a diet that consists of mother's own milk or donor human milk and bovine-based human milk fortifier plus a fixed amount of commercially available hydrolyzed bovine protein. The study intervention will begin the day after fortification is ordered and will be continued until postnatal day 50 or 32 weeks postmenstrual age, whichever occurs first. |
|
| Standard protein supplementation | Active Comparator | Infants will receive a standard diet that consists of mother's own milk or donor human milk (DHM) and bovine-based human milk fortifier. The study intervention will be continued until postnatal day 50 or 32 weeks postmenstrual age, whichever occurs first. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High protein supplementation | Dietary Supplement | To increase protein content of human milk, a fixed amount of commercially available hydrolyzed bovine protein will be added to fortified human milk. With this pragmatic approach, preterm infants assigned to the high protein supplementation group will receive > 4.5 g/kg/day of enteral protein after establishment of full enteral feeding. |
| Measure | Description | Time Frame |
|---|---|---|
| Infant body composition | Percent body fat estimated by air displacement plethysmography | Assessed at 36 weeks of postmenstrual age or at 3 months of corrected age |
| Measure | Description | Time Frame |
|---|---|---|
| Infant body composition | Percent body fat estimated by air displacement plethysmography | Assessed at 36 weeks of postmenstrual age or hospital discharge (whichever occurs first) |
| Growth | Weekly weight gain in grams |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in intestinal microbiome | Determined by molecular analyses of bacteria in fecal samples | Birth to 3 months of corrected age |
| Changes in metabolic pathways | Determined by molecular analyses of serum samples |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ariel A. Salas, MD, MSPH | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34183770 | Background | Salas AA, Jerome M, Finck A, Razzaghy J, Chandler-Laney P, Carlo WA. Body composition of extremely preterm infants fed protein-enriched, fortified milk: a randomized trial. Pediatr Res. 2022 Apr;91(5):1231-1237. doi: 10.1038/s41390-021-01628-x. Epub 2021 Jun 28. |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Clinicians and technicians responsible for the assessment of infant body composition will be masked.
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| Standard protein supplementation | Dietary Supplement | Infants assigned to the standard protein supplementation group will receive fortified human milk (< 4.5 g/kg/day of enteral protein) |
|
| Birth to 3 months of corrected age |
| Length | Weekly length in cm | Birth to 3 months of corrected age |
| Head circumference | Weekly head circumference in cm | Birth to 3 months of corrected age |
| Body mass index | Weight and height will be combined to report BMI in kg/m^2 | Birth to 3 months of corrected age |
| Necrotizing enterocolitis | Number of participants with diagnosis of necrotizing enterocolitis stage 2 or 3 | Postnatal day 14 to postnatal day 120 or discharge, whichever occurs first |
| Death | Postnatal day 14 to postnatal day 120 or discharge, whichever occurs first |
| Birth to 3 months of corrected age |
| D000091642 | Urogenital Diseases |