Preterm Infants
Conditions
Brief summary
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.
Interventions
OTHERselenium and sodium selenate supplementation
Parenteral nutrition with selenium and sodium selenate supplementation of infant formula
OTHERselenium and sodium selenite supplementation
Parenteral nutrition with selenium and sodium selenite supplementation of infant formula
OTHERWithout selenium and sodium selenate supplementation
Parenteral nutrition without selenium and sodium selenate supplementation of infant formula
OTHERWithout selenium and sodium selenite supplementation
Parenteral nutrition without selenium and sodium selenite supplementation of infant formula
Sponsors
Abbott Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Weight less than 1500 g at birth * Not capable of receiving enteral feedings prior to 7 days postnatally
Exclusion criteria
* Metabolic abnormalities such as inborn errors of metabolism * Current viral infections * Enterocolitis confirmed by diagnosis * Presence of congenital anomalies, severe cardiac disease, liver disease, severe renal and neurological diseases, cholestasis, hemolytic disease and severe gastrointestinal disease * Evidence of chronic white blood cell disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Selenium | Change from Baseline to Discharge (~50-60 days) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length | Change from study day 1 to study exit (~50-60 days) | Length at study day 1, at first enteral feed, at full enteral feeding, and at study exit |
| Head Circumference | Change from study day 1 to study exit (~50-60 days) | Head circumference at study day 1, at first enteral feed, at full enteral feeding, and at study exit |
| Intake | Change from study day 1 to study exit (~50-60 days) | Daily recording of volume and calories from parenteral solutions and study formula consumed |
| Serum Copper | Change from Baseline to Discharge (~50-60 days) | 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 |
| Weight | Change from study day 1 to study exit (~50-60 days) | Weight at study day 1, at first enteral feed, at full enteral feeding, and at study exit |
| WBC Super oxide dismutase (SOD) activity | Change from Baseline to Discharge (~50-60 days) | 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 |
| Glutathione peroxidase (GSHpx) activity | Change from Baseline to Discharge (~50-60 days) | 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 |
| Plasma GSHpx activity | Change from Baseline to Discharge (~50-60 days) | 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 |
| Plasma Amino Acid Concentrations | Change from Baseline to Discharge (~50-60 days) | 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 |
| Serum Zinc | Change from Baseline to Discharge (~50-60 days) | 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 |
Countries
United States
Outcome results
None listed