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Completed

NCT Number: NCT02758834

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

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

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Key information

Age range

24 week–32 week

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Change of plasma phytosterol concentrations in preterm infants during parenteral nutrition and after only lipid stopping.

    Time frame: 7, 14, 21, 28, 35, 42 and 49 days

    Plasma campesterol, stigmasterol and sitosterol concentrations will be measured at 7, 14, 21, 28, 35, 42 and 49 days from PN started. Plasma phytosterol concentrations will be measured by gas chromatography-mass spectrometry. Calibration curves will be used to calculate the phytosterol plasma concentrations (mg/L).

Secondary outcomes

  1. Normal liver function of preterm infants will be define by conjugated bilirubin values from blood samples under 1 mg/dl.

    Time frame: 7 days and 42 days of life

    Eligibility of preterm infants will be related to a normal liver function. Conjugated bilirubin value from blood sample is a good sign of hepatic function. The threshold value was defined to 1 mg/dl. Preterm infants who will have conjugated bilirubin values more of 1 mg/dl will be excluded from the study. The measure of conjugated bilirubin from blood samples will be routinely done at 7 and 42 days of life.

  2. Plasma phytosterols half-lives

    Time frame: After the collection of 3 or more blood samples collected when the lipid infusion is stopped.

    Plasma phytosterol half-lives (days) will be measured using 3 or more plasma phytosterol concentrations calculated after only lipid stopping. Half-life of plasma phytosterols will be calculated from monoexponential decay curves.

Sponsors and collaborators

Lead sponsor

Università Politecnica delle Marche

Other

Registry information

Official study title

Half-life of Plasma Phytosterols in Very Low-birth-weight Preterm Infants on Routine Parenteral Nutrition With Soy-bean Oil Based Lipid Emulsions

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 3, 2016
Registry last updated
May 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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