Half-life of Plasma Phytosterols in Very Low Birth Weight Preterm Infants With Parenteral Nutrition-associated Cholestasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 主要终点
- Change of plasma phytosterol concentrations in preterm infants during parenteral nutrition and after only intravenous lipid stopping
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 24 Weeks 至 32 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •severe malformations;
- •inborn errors of metabolism;
- •severe congenital sepsis;
- •normal liver functions (plasma conjugated bilirubin under 1 mg/dl during vegetable oil-lipid infusion).
结局指标
主要结局
Change of plasma phytosterol concentrations in preterm infants during parenteral nutrition and after only intravenous lipid stopping
时间窗: 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).
次要结局
- 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)
- 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.)
研究者
Virgilio Paolo Carnielli
MD, Phd, Professor of Neonatal Pediatrics at Polytechnical University of Marche (Ancona, Italy)
Università Politecnica delle Marche