Ursodeoxycholic Acid Prevents Total Parenteral Nutrition Cholestasis

NCT05043194 | Unknown

• 1 other identifier: wei liu
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cholestasis of Parenteral Nutrition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The γ-GT activity level of participants

  up to 10 weeks

Study Arms (2)

ursodeoxycholic acid arm

EXPERIMENTAL

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 .

Drug: Ursodeoxycholic Acid 250 Mg Oral Capsule

the control arm

SHAM COMPARATOR

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 .

Drug: Ursodeoxycholic Acid 250 Mg Oral Capsule

Interventions

Ursodeoxycholic Acid 250 Mg Oral Capsule DRUG

prevention

the control arm; ursodeoxycholic acid arm

Eligibility Criteria

• Age: 1 Day - 28 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• admission to the hospital within 24 hours after birth
• gestational ages:28-32 weeks
• requiring TPN during the first days of life

You may not qualify if:

• 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

Sponsors & Collaborators

• Wei Liu: lead

Study Sites (1)

Wei Liu

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Interventions

Ursodeoxycholic Acid

Intervention Hierarchy (Ancestors)

Deoxycholic Acid; Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes

Study Officials

• liwen chang

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 1, 2021
• First Posted: September 14, 2021
• Study Start: January 1, 2021
• Primary Completion: September 30, 2021
• Study Completion: July 30, 2022
• Last Updated: September 20, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)