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

NCT02758834
DG-469

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

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Data sourced from clinicaltrials.gov

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