Half-life of Plasma Phytosterols in Very Low-birth-weight Preterm Infants on Routine Parenteral Nutrition With Soy-bean Oil Based Lipid Emulsions
Half-life of Plasma Phytosterols in Preterm Infants on Parenteral Nutrition
Lead sponsor: Università Politecnica delle Marche
|Source||Università Politecnica delle Marche|
The purpose of this study is to determine plasma phytosterols half-lives in preterm infants who received intravenous soy oil-based lipid emulsions.
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.
|Start Date||January 2014|
|Completion Date||April 2016|
|Primary Completion Date||April 2016|
Sampling method: Probability Sample
Inclusion Criteria: - 24 weeks < gestational age < 32 weeks; - 500 g ≤ birth weight < 1250 g; - parenteral nutrition with soy oil-based lipid emulsions from the first hours of life; - parental consent. Exclusion Criteria: - length of parenteral nutrition > 24 days; - severe malformations; - inborn errors of metabolism; - severe congenital sepsis; - liver dysfunctions.
- 24 weeks < gestational age < 32 weeks;
- 500 g ≤ birth weight < 1250 g;
- parenteral nutrition with soy oil-based lipid emulsions from the first hours of life;
- parental consent.
- length of parenteral nutrition > 24 days;
- severe malformations;
- inborn errors of metabolism;
- severe congenital sepsis;
- liver dysfunctions.
Minimum age: 24 Weeks
Maximum age: 32 Weeks
Healthy volunteers: No
Responsible party type: Principal Investigator
Investigator affiliation: Università Politecnica delle Marche
Investigator full name: Virgilio Paolo Carnielli
Investigator title: MD, Phd
|Has Expanded Access||No|
|Study Design Info||
Observational model: Cohort
Time perspective: Prospective