KCT0006184尚未招募未知
Effect of fish oil-based lipid emulsion on prevention of parenteral nutrition-associated cholestasis in gastrointestinal surgical infants
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- o Limit 至 3??(Month)（—）
- 性别
- All
入选标准
- •1. Infants under 3 months of age who have undergone gastrointestinal surgery*
- •2.Direct bilirubin less than 1.0 mg/dL
- •3. Expect to use PN for more than 2 weeks in the future
- •4. The ratio of calories supplied by oral nutrition to the total calories is less than 60%
- •5. 1,000 g or more in weight
- •6. At least 25 weeks gestational age at birth
- •*Gastrointestinal surgery: necrotizing enterocolitis (NEC), spontaneous intestinal perforation, intestinal atresia, gastrointestinal motility disorder, congenital abdominal hernia/abdominal wall rupture (omphalocele/gastroschisis), intestinal malroation, meconium peritonitis, and other causes such as necrosis of the small and large intestine. .
排除标准
- •1.Basic diseases: Patients diagnosed with congenital diseases that can cause biliary stasis (congenital or acquired TORCH syndrome, syphilis, HIV, hepatitis B or C, metabolic or primary liver diseases, biliary atresia, intra- or extrahepatic diseases obstructing bile flow) )
- •2. Patients with neonatal sepsis or hemodynamically unstable condition requiring the use of a booster
- •3. Patients with severe blood clotting disorder (platelet count less than 150,000/mm3, INR 2.0 or more)
- •4. Patients taking anticoagulants
- •5. Patients with dyslipidemia or severe hyperlipidemia
- •6. Patients with severe liver failure or kidney failure
- •7. Patients with contraindications to jugular vein nutrition
- •8. Patients with hypersensitivity to fish, eggs, soybeans, peanut protein, or the active ingredients or additives of this drug
- •9. Patients with signs or symptoms of anaphylactic reaction (fever, tremor, rash, shortness of breath, etc.)
- •10. General contraindications of fluid therapy: patients with acute pulmonary edema, patients with excessive fluid supply, patients with target dysfunction, heart failure
- •11. Patients participating in other clinical studies
研究者
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