drugset / Trial / NCT05043194
Ursodeoxycholic Acid Prevents Total Parenteral Nutrition Cholestasis
RandomizedParallel-groupQuadruple-blindPrevention
Summary
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.
Timeline
- Start
- 2021-01-01
- Primary completion
- 2021-09-30
- Completion
- 2022-07-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ursodeoxycholic Acid | Small molecule | 20 mg/kg | Oral |
| Subject | Ursodeoxycholic Acid | Small molecule | 25 mg/kg | Oral |