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

January 22, 2018 updated by: Virgilio Paolo Carnielli, Università Politecnica delle Marche
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

37

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 months to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Preterm infants (24 < gestational age < 32 weeks; 500 g ≤ birth weight < 1250 g) with parenteral nutrition-associated cholestasis.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 77 and 84 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università Politecnica delle Marche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

September 6, 2016

First Submitted That Met QC Criteria

October 25, 2016

First Posted (Estimate)

October 28, 2016

Study Record Updates

Last Update Posted (Actual)

January 24, 2018

Last Update Submitted That Met QC Criteria

January 22, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DG469

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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