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Trial record 46 of 581 for:    bilirubin AND liver function

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

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ClinicalTrials.gov Identifier: NCT02758834
Recruitment Status : Completed
First Posted : May 3, 2016
Last Update Posted : May 3, 2016
Sponsor:
Information provided by (Responsible Party):
Virgilio Paolo Carnielli, Università Politecnica delle Marche

Brief Summary:
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
Liver Diseases

Detailed Description:
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.

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Study Type : Observational
Actual Enrollment : 45 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Half-life of Plasma Phytosterols in Very Low-birth-weight Preterm Infants on Routine Parenteral Nutrition With Soy-bean Oil Based Lipid Emulsions
Study Start Date : January 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016



Primary Outcome Measures :
  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 Outcome Measures :
  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.


Biospecimen Retention:   Samples Without DNA
Plasma.


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Ages Eligible for Study:   24 Weeks to 32 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02758834


Sponsors and Collaborators
Università Politecnica delle Marche
Investigators
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Principal Investigator: Virgilio P. Carnielli, MD, PhD Università Politecnica delle Marche

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Virgilio Paolo Carnielli, MD, Phd, Università Politecnica delle Marche
ClinicalTrials.gov Identifier: NCT02758834     History of Changes
Other Study ID Numbers: DG-469
First Posted: May 3, 2016    Key Record Dates
Last Update Posted: May 3, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Virgilio Paolo Carnielli, Università Politecnica delle Marche:
Preterm Infants
Phytosterols
Parenteral Nutrition

Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases