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
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.

Overall Status Completed
Start Date January 2014
Completion Date April 2016
Primary Completion Date April 2016
Study Type Observational
Primary Outcome
Measure Time Frame
Change of plasma phytosterol concentrations in preterm infants during parenteral nutrition and after only lipid stopping. 7, 14, 21, 28, 35, 42 and 49 days
Secondary Outcome
Measure Time Frame
Normal liver function of preterm infants will be define by conjugated bilirubin values from blood samples under 1 mg/dl. 7 days and 42 days of life
Plasma phytosterols half-lives After the collection of 3 or more blood samples collected when the lipid infusion is stopped.
Enrollment 45

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.

Gender: All

Minimum age: 24 Weeks

Maximum age: 32 Weeks

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Virgilio P. Carnielli, MD, PhD Principal Investigator Università Politecnica delle Marche
Verification Date

April 2016

Responsible Party

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
Condition Browse
Patient Data Undecided
Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov