Effect of Increased Enteral Protein on Body Composition of Preterm Infants
NCT ID: NCT03586102
Last Updated: 2025-05-28
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
56 participants
INTERVENTIONAL
2018-08-23
2025-04-24
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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High protein supplementation
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.
High protein supplementation
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.
Standard protein supplementation
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.
Standard protein supplementation
Infants assigned to the standard protein supplementation group will receive fortified human milk (\< 4.5 g/kg/day of enteral protein)
Interventions
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High protein supplementation
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.
Standard protein supplementation
Infants assigned to the standard protein supplementation group will receive fortified human milk (\< 4.5 g/kg/day of enteral protein)
Eligibility Criteria
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Inclusion Criteria
* Feeding volumes of ≥120 ml/kg/day before or on postnatal day 14.
Exclusion Criteria
* Gastrointestinal or neurologic malformations.
1 Day
21 Days
ALL
No
Sponsors
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Children's Health System, Alabama
OTHER
University of Alabama at Birmingham
OTHER
Responsible Party
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Ariel A. Salas
Assistant Professor
Principal Investigators
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Ariel A. Salas, MD, MSPH
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Countries
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References
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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.
Other Identifiers
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300000681
Identifier Type: -
Identifier Source: org_study_id
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