Ursodiol for Treating Parenteral Nutrition Associated Cholestasis in Neonates
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Length of parenteral nutrition associated cholestasis (in days)
研究概览
简要总结
The purpose of this study is to determine whether ursodiol is effective in the treatment of parenteral nutrition associated cholestasis in neonates.
详细描述
This is the first randomised controlled study that address the question of the role of ursodiol as treatment of cases of PNAC.
It includes all neonates with stratification of less than and equal to 32 weeks or more than 32 weeks of gestation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm or in-term newborns hospitalized in neonatal care units at CHU Sainte-Justine between October 1st 2008 and October 1st
- •Must be receiving parenteral nutrition (either partial or total) at the diagnosis of cholestasis.
- •Parental Consent must be obtained.
排除标准
- •Active urinary tract infection
- •Presence of clinical signs(acholic stool) of or ultrasound evidence of biliary tract anomalies.
- •Positive TORCH infections(Toxoplasmosis, Other infections, Rubella, Cytomegalovirus, Herpes simplex virus)
- •Known short bowel syndrome
- •Known congenital hypothyroidism
- •Known genetic disorders associated with cholestasis like galactosemia, phenylcytonuria, antitrypsin 1 deficiency... etc
研究组 & 干预措施
Ursodiol
Participants assigned in this arm receive an ursodiol suspension at 20mg/ml.
干预措施: Ursodiol (Drug)
placebo
A placebo suspension that looks like the ursodiol suspension used.
干预措施: placebo (Drug)
结局指标
主要结局
Length of parenteral nutrition associated cholestasis (in days)
时间窗: at the end of cholestasis (when conjugated bilirubin < 34 mmol/L) average of 4 weeks.
次要结局
- Peak value of biomarkers associated with cholestasis (Gamma-glutamyl transpeptidase, Alkaline phosphatase, conjugated bilirubin)(at least once a week, during cholestasis)
- 1- Other hepatic marker (Aspartate transaminase, alanine transaminase, albumin blood level)(at least once a week, during cholestasis)
- Length required to minimal enteral feeding (120mL/kg/day) measured in days.(From birth to outcome (usually less than 21 days))
- Weight gain (in g/kg/day)(From birth to resolution of cholestasis (very varuiable but usually less than 3 months))
- Adverse effects linked to ursodiol(From beginning to the end of the medication (average 4 weeks))
研究者
Ibrahim Mohamed
Assisstant professor of pediatrics
St. Justine's Hospital