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The overall objective of the proposal is to demonstrate the feasibility of providing increased calories and protein in the first week of life to very low birth weight (VLBW) preterm infants.
Infants will be randomized to receive either standard parenteral nutrition via the neonatal intensive care unit (NICU) protocol or enhanced parenteral nutrition via the Study protocol during their first week of life through higher initial macronutrient provision and faster advancement of macronutrient provision.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced Nutrition | Experimental | Infants randomized to the study protocol will start on higher initial amounts of calories, proteins and fats. They will also undergo faster increases of these nutrients during their first week of life. |
|
| Standard Nutrition | Active Comparator | Infants randomized to the standard nutrition protocol will start on standard amounts of calories, proteins and fats per the usual NICU routine. They will also undergo standard increases of these nutrients during their first week of life. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced Intravenous Nutrition | Other | Increased macronutrients for first 7 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome measure will be the amount of nutrition ( kcals/kg/day and amount of protein g/kg/day and amount of lipids g/kg/day) received in the first week of life. | We will calculate the actual amount of protein, kcals, lipids etc received in both groups at the end of the first week to determine if we were able to deliver increased amounts of nutrition to the enhanced protocol group | 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sara E Ramel, MD | University of Minnesota Masonic Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota Masonic Children's Hospital | Minneapolis | Minnesota | 55454 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36812894 | Derived | Nagel EM, Gonzalez V JD, Bye JK, Super J, Demerath EW, Ramel SE. Enhanced Parenteral Nutrition Is Feasible and Safe in Very Low Birth Weight Preterm Infants: A Randomized Trial. Neonatology. 2023;120(2):242-249. doi: 10.1159/000527552. Epub 2023 Feb 22. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 28, 2017 | Jul 28, 2017 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 18, 2017 | Jul 28, 2017 | 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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Infants will be randomized to receive either standard parenteral nutrition via the NICU protocol or enhanced parenteral nutrition via the Study protocol during their first week of life through higher initial macronutrient provision and faster advancement of macronutrient provision.
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Parents, participant and Outcomes assessor will be blinded to the nutritional intervention group.
| Standard Intravenous Nutrition |
| Other |
Standard macronutrients for first 7 days |
|
| D000091642 | Urogenital Diseases |