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| ID | Type | Description | Link |
|---|---|---|---|
| 000538159 | Other Grant/Funding Number | Mead Johnson Nutrition |
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| Name | Class |
|---|---|
| Mead Johnson Nutrition | INDUSTRY |
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In this proposed clinical trial, the investigators will randomize 80 very preterm (VPT) infants to receive either early (between day 4 and 7) or delayed (between day 10 and 14) fortification and determine if providing early protein supplementation through early fortification results in higher FFM-for-age z scores and more diversity in the gut microbiome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early human milk fortification (HMF) group | Experimental | A human milk fortifier will be added to the feeds between days 4 to 7, after a total feeding volume greater than 120 ml/kg/day is achieved. |
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| Delayed human milk fortification (HMF) group | Active Comparator | A human milk fortifier will be added to the feeds between days 10 to 14, after a total feeding volume greater than 120 ml/kg/day is achieved. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early HMF | Dietary Supplement | Mom's milk or donor milk will be fortified between postnatal day 4 and 7 |
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| Measure | Description | Time Frame |
|---|---|---|
| Fat-free mass(FFM)-for-age Z-score | Estimated by air displacement plethysmography | Postnatal day 14 to 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Fecal microbiome composition | Determined by 16S RNA sequencing of bacteria in stool samples | Birth to 36 weeks postmenstrual age |
| Growth - Weight | Measured weekly in grams and z scores as part of routine care |
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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 |
|---|---|---|---|
| 39986385 | Result | Salas AA, Gunawan E, Jeffcoat S, Nguyen K. Early full enteral nutrition with fortified milk in very preterm infants: a randomized clinical trial. Am J Clin Nutr. 2025 May;121(5):1117-1123. doi: 10.1016/j.ajcnut.2025.02.019. Epub 2025 Feb 21. |
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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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| Delayed HMF | Dietary Supplement | Mom's milk or donor milk will be fortified between postnatal day 10 and 14 |
|
| Birth to 36 weeks postmenstrual age or hospital discharge |
| Growth - Length | Measured weekly in cm and z scores as part of routine care | Birth to 36 weeks postmenstrual age or hospital discharge |
| Growth - Head circumference | Measured weekly in cm and z scores as part of routine care | Birth to 36 weeks postmenstrual age or hospital discharge |
| Growth rate | Weight gain in g/kg/day | Birth to 36 weeks postmenstrual age or hospital discharge |
| Number of participants with postnatal growth faltering | Diagnosis of growth faltering (decline in weight-for-age z score from birth to 36 weeks postmenstrual age greater than 1.2 | Birth to 36 weeks postmenstrual age or hospital discharge |
| Number of participants with diagnosis of necrotizing enterocolitis | Diagnosis of necrotizing enterocolitis stage 2 or 3 | Birth to 60 days or discharge |
| Number of participants with diagnosis of intestinal perforation | Diagnosis of intestinal perforation | Birth to 10 days |
| Death | Death prior to postnatal day 60 | Birth to 60 days |
| Duration of hospital stay in days | From day of admission to day of hospital discharge to home | Birth to 60 days or discharge, whichever occurs first |
| D000091642 | Urogenital Diseases |