Ignite Creation Date:
2024-05-06 @ 9:16 AM
Last Modification Date:
2024-10-26 @ 12:12 PM
Study NCT ID:
NCT02947594
Status:
COMPLETED
Last Update Posted:
2018-01-24
First Post:
2016-09-06
Brief Title:
Half-life of Plasma Phytosterols in Very Low Birth Weight Preterm Infants With Parenteral Nutrition-associated Cholestasis
Sponsor:
Università Politecnica delle Marche
Organization:
Università Politecnica delle Marche
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2018-01
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:
Parenteral nutrition-associated cholestasis PNAC is one of the most common complications resulting from administration of parenteral nutrition in neonates Excess intravenous intake of vegetable oil-based lipid emulsions containing phytosterols is felt to be a major contributing factor To date no information is available on plasma phytosterols half-lives in very-low-birth-weight VLBW preterm infants with PNAC In a prospective cohort study plasma phytosterols campesterol stigmasterol and sitosterol of VLBW preterm infants with PNAC will be measured by gas chromatography-mass spectrometry GC-MS during PN administration and also after the stop of intravenous lipid infusion Plasma phytosterols half-lives will be calculated from the monoexponential decay curves Blood samples will be weekly collected from 1st to 12th 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 -20C until analysis Saponification reaction will be done using 5-alpha-cholestane as internal standard
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None