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Half-life of Plasma Phytosterols in Very Low Birth Weight Preterm Infants With Parenteral Nutrition-associated Cholestasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02947594
Recruitment Status : Completed
First Posted : October 28, 2016
Last Update Posted : January 24, 2018
Information provided by (Responsible Party):
Virgilio Paolo Carnielli, Università Politecnica delle Marche

Brief Summary:
Parenteral nutrition-associated cholestasis (PNAC) is one of the most common complications resulting from administration of parenteral nutrition in neonates. Excess intravenous intake of vegetable oil-based lipid emulsions containing phytosterols is felt to be a major contributing factor. To date, no information is available on plasma phytosterols half-lives in very-low-birth-weight (VLBW) preterm infants with PNAC. In a prospective cohort study, plasma phytosterols (campesterol, stigmasterol and sitosterol) of VLBW preterm infants with PNAC will be measured by gas chromatography-mass spectrometry (GC-MS) during PN administration and also after the stop of intravenous lipid infusion. Plasma phytosterols half-lives will be calculated from the monoexponential decay curves. Blood samples will be weekly collected from 1st to 12th 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.

Condition or disease
Liver Disease

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Study Type : Observational
Actual Enrollment : 37 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : January 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : February 2017

Primary Outcome Measures :
  1. Change of plasma phytosterol concentrations in preterm infants during parenteral nutrition and after only intravenous lipid stopping [ Time Frame: 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 77 and 84 days ]
    Plasma campesterol, stigmasterol and sitosterol concentrations will be measured at 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 77 and 84 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 :
  1. Liver dysfunction in preterm infants will be defined by conjugated bilirubin values from blood samples over 1 mg/dl [ Time Frame: Routinely checked at 7 and 42 days of life. Additional measure of conjugated bilirubin will be performed after 15 days if the value continues to be higher than 1 mg/dl. ]
    Eligibility of preterm infants will be related to liver function. Conjugated bilirubin value from blood sample is a good sign of hepatic function. The threshold value was defined to 1 mg/dl. Just preterm infants who will have conjugated bilirubin values more of 1 mg/dl will be included in the study. Conjugated bilirubin will be measured at 7 and 42 days of life on routine care. When the conjugated bilirubin value will be higher than 1 mg/dl, the analysis will be repeated every 15 days until it returns under the threshold value (1 mg/dl). Parenteral nutrition-associated cholestasis will be only diagnosed in patients with pathological values of conjugated bilirubin (over 1 mg/dl) during vegetable oil-lipid infusion.

  2. Plasma phytosterols half-lives [ Time Frame: We will able to measure the plasma phytosterol half-lives (days) after the analysis of 3 or more blood samples collected from the stop of lipid infusion to 84 days of life ]
    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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Ages Eligible for Study:   24 Weeks to 32 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Preterm infants (24 < gestational age < 32 weeks; 500 g ≤ birth weight < 1250 g) with parenteral nutrition-associated cholestasis.

Inclusion Criteria:

  • 24 weeks < gestational age < 32 weeks;
  • 500 g ≤ birth weight < 1250 g;
  • parenteral nutrition with vegetable oil-based lipid emulsions from the first hours of life;
  • diagnosis of cholestasis during vegetable oil-lipid infusion (plasma conjugated bilirubin value > 1 mg/dl)
  • parental consent;

Exclusion Criteria:

  • severe malformations;
  • inborn errors of metabolism;
  • severe congenital sepsis;
  • normal liver functions (plasma conjugated bilirubin under 1 mg/dl during vegetable oil-lipid infusion).

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Responsible Party: Virgilio Paolo Carnielli, MD, Phd, Professor of Neonatal Pediatrics at Polytechnical University of Marche (Ancona, Italy), Università Politecnica delle Marche Identifier: NCT02947594    
Other Study ID Numbers: DG469
First Posted: October 28, 2016    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases