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Current NICU protocol introduces human milk fortifier at 8 days of feeding. This study will introduce human milk fortifier at day 1. The primary outcome is the effect on growth velocity at 28 days and 36 weeks post menstrual age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Continue current NICU feeding protocol, introducing human milk fortifier at 8 days | |
| Intervention | Experimental | Introducing human milk fortifier at 1 day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human milk fortifier | Dietary Supplement | Human milk fortifier added to human breast milk at day 1 vs day 8 of feeds |
|
| Measure | Description | Time Frame |
|---|---|---|
| Growth velocity | weight gain in grams/kg/day | at 28 days of life |
| Measure | Description | Time Frame |
|---|---|---|
| Growth velocity | weight gain in grams/kg/day | at 36 weeks post menstrual age |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zanna Wynter, DO | Contact | 770-608-0868 | zwynter@augusta.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Georgia | Recruiting | Augusta | Georgia | 30912 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38724605 | Derived | Wynter Z, Gorham JA, Thompson AB, Mundy C, Waller JL, Stansfield BK. Immediate fortification of human milk with a bovine milk-derived human milk fortifier in very low birth weight infants: a randomized clinical trial. J Perinatol. 2024 Nov;44(11):1591-1596. doi: 10.1038/s41372-024-01998-0. Epub 2024 May 9. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 4, 2022 | Jul 19, 2022 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 5, 2022 | Jul 19, 2022 | ICF_001.pdf |
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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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2 groups. 1 group will be controlled, following standard NICU feeding protocol. 1 group will be intervention, receiving early introduction of human milk fortifier to enteral feeds.
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| D000091642 | Urogenital Diseases |