An interventional study of selenium and sodium selenate supplementation and selenium and sodium selenite supplementation in Preterm Infants, sponsored by Abbott Nutrition. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2014-02-19.
Sponsored by Abbott Nutrition · Not applicable and Interventional
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.
Abbott Nutrition is the lead sponsor of 153 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Parenteral nutrition (PN) with selenium and sodium selenate supplementation of infant formula
Other: selenium and sodium selenate supplementation
Parenteral nutrition (PN) with selenium and sodium selenite supplementation of infant formula
Other: selenium and sodium selenite supplementation
Parenteral nutrition (PN) without selenium and sodium selenate supplementation of infant formula
Other: Without selenium and sodium selenate supplementation
Parenteral nutrition (PN) without selenium and sodium selenite supplementation of infant formula
Other: Without selenium and sodium selenite supplementation
Parenteral nutrition with selenium and sodium selenate supplementation of infant formula
Parenteral nutrition with selenium and sodium selenite supplementation of infant formula
Parenteral nutrition without selenium and sodium selenate supplementation of infant formula
Parenteral nutrition without selenium and sodium selenite supplementation of infant formula
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
Time frame: Change from Baseline to Discharge (~50-60 days)
Weight
Weight at study day 1, at first enteral feed, at full enteral feeding, and at study exit
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Change from Baseline to Discharge (~50-60 days)
This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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Abbott Nutrition