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The objectives of the study were to assess the serum selenium, zinc, and copper status and plasma and white blood cell antioxidant enzyme activities of low birth weight infants receiving selenium supplemented and non-selenium supplemented parenteral nutrition from initiation of parenteral nutrition until discontinuation of preterm formula or hospital discharge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PN selenium and formula sodium selenate | Experimental | Parenteral nutrition (PN) with selenium and sodium selenate supplementation of infant formula |
|
| PN selenium and formula sodium selenite | Experimental | Parenteral nutrition (PN) with selenium and sodium selenite supplementation of infant formula |
|
| PN without selenium and formula sodium selenate | Experimental | Parenteral nutrition (PN) without selenium and sodium selenate supplementation of infant formula |
|
| PN without selenium and formula sodium selenite | Experimental | Parenteral nutrition (PN) without selenium and sodium selenite supplementation of infant formula |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| selenium and sodium selenate supplementation | Other | Parenteral nutrition with selenium and sodium selenate supplementation of infant formula |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum Selenium | 4 timepoints include 1) baseline prior to initiation of parenteral nutrition; 2) initiation of enteral nutrition; 3) at discontinuation of parenteral nutrition; 4) at discontinuation of preterm formula/discharge | Change from Baseline to Discharge (~50-60 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Weight at study day 1, at first enteral feed, at full enteral feeding, and at study exit | Change from study day 1 to study exit (~50-60 days) |
| Length | Length at study day 1, at first enteral feed, at full enteral feeding, and at study exit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marlene Borschel, Ph.D | Abbott Nutrition | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Legacy Emanuel Children's Hospital | Portland | Oregon | 97227 | United States |
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| selenium and sodium selenite supplementation | Other | Parenteral nutrition with selenium and sodium selenite supplementation of infant formula |
|
| Without selenium and sodium selenate supplementation | Other | Parenteral nutrition without selenium and sodium selenate supplementation of infant formula |
|
| Without selenium and sodium selenite supplementation | Other | Parenteral nutrition without selenium and sodium selenite supplementation of infant formula |
|
| Change from study day 1 to study exit (~50-60 days) |
| Head Circumference | Head circumference at study day 1, at first enteral feed, at full enteral feeding, and at study exit | Change from study day 1 to study exit (~50-60 days) |
| Intake | Daily recording of volume and calories from parenteral solutions and study formula consumed | Change from study day 1 to study exit (~50-60 days) |
| Serum Copper | 4 timepoints include 1) baseline prior to initiation of parenteral nutrition; 2) initiation of enteral nutrition; 3) at discontinuation of parenteral nutrition; 4) at discontinuation of preterm formula/discharge | Change from Baseline to Discharge (~50-60 days) |
| Serum Zinc | 4 timepoints include 1) baseline prior to initiation of parenteral nutrition; 2) initiation of enteral nutrition; 3) at discontinuation of parenteral nutrition; 4) at discontinuation of preterm formula/discharge | Change from Baseline to Discharge (~50-60 days) |
| WBC Super oxide dismutase (SOD) activity | 4 timepoints include 1) baseline prior to initiation of parenteral nutrition; 2) initiation of enteral nutrition; 3) at discontinuation of parenteral nutrition; 4) at discontinuation of preterm formula/discharge | Change from Baseline to Discharge (~50-60 days) |
| Glutathione peroxidase (GSHpx) activity | 4 timepoints include 1) baseline prior to initiation of parenteral nutrition; 2) initiation of enteral nutrition; 3) at discontinuation of parenteral nutrition; 4) at discontinuation of preterm formula/discharge | Change from Baseline to Discharge (~50-60 days) |
| Plasma GSHpx activity | 4 timepoints include 1) baseline prior to initiation of parenteral nutrition; 2) initiation of enteral nutrition; 3) at discontinuation of parenteral nutrition; 4) at discontinuation of preterm formula/discharge | Change from Baseline to Discharge (~50-60 days) |
| Plasma Amino Acid Concentrations | 4 timepoints include 1) baseline prior to initiation of parenteral nutrition; 2) initiation of enteral nutrition; 3) at discontinuation of parenteral nutrition; 4) at discontinuation of preterm formula/discharge | Change from Baseline to Discharge (~50-60 days) |
| ID | Term |
|---|---|
| D012643 | Selenium |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008903 | Minerals |
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