Half-life of Plasma Phytosterols in Preterm Infants on Parenteral Nutrition
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ClinicalTrials.gov Identifier: NCT02758834
Recruitment Status :
First Posted : May 3, 2016
Last Update Posted : May 3, 2016
Università Politecnica delle Marche
Information provided by (Responsible Party):
Virgilio Paolo Carnielli, 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.
Condition or disease
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.
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 Outcome Measures :
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.
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.
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Layout table for eligibility information
Ages Eligible for Study:
24 Weeks to 32 Weeks (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Preterm infants (24 weeks < gestational age < 32 weeks; 500 g ≤ birth weight < 1250 g) who received intravenous soy oil-based lipid emulsions from the first hours of life.
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;