NCT05043194

Ursodeoxycholic Acid Prevents Total Parenteral Nutrition Cholestasis

The Preventive Study of Ursodeoxycholic Acid(UDCA) on Total Parenteral Nutrition Cholestasis(PNAC) in Premature Infants

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Wei Liu · Academic / Other
• Sex: All
• Age: 1 Day – 28 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Cholestasis of Parenteral Nutrition

Interventions

Type	Name	Description
DRUG	Ursodeoxycholic Acid 250 Mg Oral Capsule	prevention

Timeline

• Start date: 2021-01-01
• Primary completion: 2021-09-30
• Completion: 2022-07-30
• First posted: 2021-09-14
• Last updated: 2021-09-20

Locations

1 site across 1 country: China