Ursodeoxycholic Acid Prevents Total Parenteral Nutrition Cholestasis

Cholestasis of Parenteral Nutrition Clinical Trial

— UDACPPNAC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05043194
• Other study ID #: wei liu
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: July 30, 2022

Study information

• Verified date: September 2021
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 30, 2022
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Years

Eligibility

Inclusion Criteria:

1. admission to the hospital within 24 hours after birth

2. gestational ages:28-32 weeks

3. requiring TPN during the first days of life

Exclusion Criteria:

1. major congenital abnormalities, chromosomal abnormality congenital intrauterine infection, genetic metabolic diseases structural liver abnormality

2. surgical treatment was taken during hospitalization

3. with severe symptoms of digestive system disease before TPN

4. incompletion or withdrawal of treatment during hospitalization

Related Conditions & MeSH terms

• Cholestasis
• Cholestasis of Parenteral Nutrition

Intervention

Drug:
• Ursodeoxycholic Acid 250 Mg Oral Capsule
prevention

Locations

Country	Name	City	State
China	Wei Liu	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Wei Liu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	direct bilirubin value of participants	Weekly direct bilirubin values in µmol/L for preterm infants during hospitalization will be collected to assess the severity of cholestasis	up to 10 weeks
Secondary	The ?-GT activity level of participants	Weekly ?-GT values in U/L for preterm infants during hospitalization will be collected to assess the severity of cholestasis	up to 10 weeks