Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-02-26 @ 10:30 PM
Study NCT ID:
NCT02758834
Status:
COMPLETED
Last Update Posted:
2016-05-03
First Post:
2016-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Half-life of Plasma Phytosterols in Preterm Infants on Parenteral Nutrition
Sponsor:
Università Politecnica delle Marche
Organization:
Study Overview
Official Title:
Half-life of Plasma Phytosterols in Very Low-birth-weight Preterm Infants on Routine Parenteral Nutrition With Soy-bean Oil Based Lipid Emulsions
Status:
COMPLETED
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine plasma phytosterols half-lives in preterm infants who received intravenous soy oil-based lipid emulsions.
Detailed Description:
Several studies reported the relationship between plasma phytosterol concentrations and parenteral nutrition-associated cholestasis (PNAC). Information on plasma phytosterols half-lives in very-low-birth-weight (VLBW) preterm infants on lipid parenteral nutrition (PN) are lacking. In a prospective cohort study, plasma phytosterols (campesterol, stigmasterol and sitosterol) of VLBW preterm infants on routine PN will be measured by gas chromatography-mass spectrometry (GC-MS) during PN administration and after only lipid stopping. Plasma phytosterols half-lives will be calculated from the monoexponential decay curves. Blood samples will be weekly collected from 1st to 7th week of life during routine metabolic tolerance analysis or gas-analysis in order to avoid burden of additional phlebotomy. Samples will be collected in ethylenediaminetetraacetic acid-tubes and immediately centrifugated. Plasma will be stored in pyrogallol added-tubes at -20°C until analysis. Saponification reaction will be done using 5-alpha-cholestane as internal standard.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: