NCT01555957已完成3 期
Effect of Lipid Intake on Direct Hyperbilirubinemia in Late Preterm and Term Infants With Gastrointestinal Surgical Problems.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of Participants With Parenteral Nutrition Associated Cholestasis
研究概览
简要总结
The Investigators hypothesize that increased cumulative amount of lipid intake causes PNAC in late preterm and term neonates with major GI surgical disorders
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
The care taker team provided daily weight to the research pharmacist for calculating the dose of the lipid according to the assignment and then calculated the rate of administration over 18 to 24 hours depending on the volume. The rate and dose was masked to the investigators and participants.
入排标准
- 年龄范围
- — 至 72 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All neonates ≥ 34 weeks gestational age with major GI surgical disorders (Gastroschisis, omphalocele, volvulus, trachea-esophageal fistula, duodenal atresia, jejunal atresia, ileal atresia, hirschsprung's disease, anorectal malformation, intestinal obstruction, and GI perforations) requiring surgery admitted to our NICU within first 72 hours will be eligible for this study
排除标准
- •If does not need TPN by 72 hours;
- •Direct hyperbilirubinemia within the first 72 hours after birth;
- •TORCH infections (Toxoplasmosis, CMV, Herpes, Rubella, HIV, etc);
- •Biliary tract disorders leading to direct hyperbilirubinemia;
- •Known metabolic disorders that may be associated with direct hyperbilirubinemia- such as Galactosemia, α-1 antitrypsin deficiency, etc
研究组 & 干预措施
low dose intravenous lipids
Experimental
干预措施: intravenous lipid (Drug)
high dose of intravenous lipids
Placebo Comparator
干预措施: intravenous lipid (Drug)
结局指标
主要结局
Number of Participants With Parenteral Nutrition Associated Cholestasis
时间窗: 7 weeks
Defined as direct bilirubin ≥ 2mg/dl developing within one week of the completion of 6 week randomization period
次要结局
- Mean Rate of Change in Direct Bilirubin(baseline, weeks 1, 2, 3, 4, 5 and 6)
研究者
研究点 (1)
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