Clincosm LogoSign in Get a demo

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

Sponsor
Università Politecnica delle Marche (Other)
Overall Status
Completed
CT.gov ID
NCT02947594
Collaborator
(none)
37
Enrollment
37
Duration (Months)

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    37 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Study Start Date :
    Jan 1, 2014
    Actual Primary Completion Date :
    Aug 1, 2016
    Actual Study Completion Date :
    Feb 1, 2017

    Outcome Measures

    Primary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    24 Weeks to 32 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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).

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Università Politecnica delle Marche

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Virgilio Paolo Carnielli, MD, Phd, Professor of Neonatal Pediatrics at Polytechnical University of Marche (Ancona, Italy), Università Politecnica delle Marche
    ClinicalTrials.gov Identifier:
    NCT02947594
    Other Study ID Numbers:
    • DG469
    First Posted:
    Oct 28, 2016
    Last Update Posted:
    Jan 24, 2018
    Last Verified:
    Jan 1, 2018
    Additional relevant MeSH terms:
    Liver Diseases

    Study Results

    No Results Posted as of Jan 24, 2018