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Half-life of Plasma Phytosterols in Preterm Infants on Parenteral Nutrition

U

Università Politecnica delle Marche

Status

Completed

Conditions

Liver Diseases

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

The purpose of this study is to determine plasma phytosterols half-lives in preterm infants who received intravenous soy oil-based lipid emulsions.

Full 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.

Enrollment

45 patients

Sex

All

Ages

24 to 32 weeks old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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