Trials / Completed
CompletedNCT02947594
Half-life of Plasma Phytosterols in Very Low Birth Weight Preterm Infants With Parenteral Nutrition-associated Cholestasis
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 37 (actual)
- Sponsor
- Università Politecnica delle Marche · Academic / Other
- Sex
- All
- Age
- 24 Weeks – 32 Months
- Healthy volunteers
- Not accepted
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.
Conditions
Timeline
- Start date
- 2014-01-01
- Primary completion
- 2016-08-01
- Completion
- 2017-02-01
- First posted
- 2016-10-28
- Last updated
- 2018-01-24
Source: ClinicalTrials.gov record NCT02947594. Inclusion in this directory is not an endorsement.