The Preventive Study of Ursodeoxycholic Acid(UDCA) on Total Parenteral Nutrition Cholestasis(PNAC) in Premature Infants
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- direct bilirubin value of participants
研究概览
简要总结
This study aims to confirm whether the preventive use of ursodeoxycholic acid on the 5th day after birth in preterm infants who started parenteral nutrition therapy can reduce the occurrence of enteral nutrition-related cholestasis in preterm infants. This study examined the safety and efficacy of ursodeoxycholic acid (UDCA) in preventing Cholestasis Associated with Total Parenteral Nutrition in preterm infants.
详细描述
Investigators compared oral administration of UDCA prophylaxis with no prophylaxis in a randomized, open-label, proof-of-concept trial in preterm neonates with PN therapy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 28 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •admission to the hospital within 24 hours after birth
- •gestational ages:28-32 weeks
- •requiring TPN during the first days of life
排除标准
- •major congenital abnormalities, chromosomal abnormality congenital intrauterine infection, genetic metabolic diseases structural liver abnormality
- •surgical treatment was taken during hospitalization
- •with severe symptoms of digestive system disease before TPN
- •incompletion or withdrawal of treatment during hospitalization
研究组 & 干预措施
ursodeoxycholic acid arm
Premature infants who meet the inclusion criteria take preventive oral ursodeoxycholic acid on the 7th day after birth. ursodeoxycholic acid capsules (Ursofalk, 250 mg/capsules), starting with oral administration of pharmacologic doses of 20-25mg/kg/d, twice daily, until they were discharged .
干预措施: Ursodeoxycholic Acid 250 Mg Oral Capsule (Drug)
the control arm
The control group was treated with UDCA after the occurrence of cholestasis.ursodeoxycholic acid capsules (Ursofalk, 250 mg/capsules), starting with oral administration of pharmacologic doses of 20-25mg/kg/d, twice daily, until they were discharged .
干预措施: Ursodeoxycholic Acid 250 Mg Oral Capsule (Drug)
结局指标
主要结局
direct bilirubin value of participants
时间窗: up to 10 weeks
Weekly direct bilirubin values in μmol/L for preterm infants during hospitalization will be collected to assess the severity of cholestasis
次要结局
- The γ-GT activity level of participants(up to 10 weeks)
研究者
Wei Liu
Associate Professor
Tongji Hospital