Ursodeoxycholic Acid Prevents Total Parenteral Nutrition Cholestasis

Not Applicable

• Conditions: Cholestasis of Parenteral Nutrition
• Interventions: Drug: Ursodeoxycholic Acid 250 Mg Oral Capsule

• Registration Number: NCT05043194
• Lead Sponsor: Wei Liu

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.

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.

Study Timeline

• Study Start: 2021-01-01
• Status Verified: 2021-09
• Study First Submitted: 2021-09-01
• Study First Submitted QC: 2021-09-03
• Last Update Submitted: 2021-09-13
• Study First Posted: 2021-09-14
• Last Update Posted: 2021-09-20
• Primary Completion: 2021-09-30
• Study Completion: 2022-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ursodeoxycholic acid arm	Ursodeoxycholic Acid 250 Mg Oral Capsule	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 .
the control arm	Ursodeoxycholic Acid 250 Mg Oral Capsule	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 .

Primary Outcome Measures

Name	Time	Method
direct bilirubin value of participants	up to 10 weeks	Weekly direct bilirubin values in μmol/L for preterm infants during hospitalization will be collected to assess the severity of cholestasis

Secondary Outcome Measures

Name	Time	Method
The γ-GT activity level of participants	up to 10 weeks	Weekly γ-GT values in U/L for preterm infants during hospitalization will be collected to assess the severity of cholestasis

Trial Locations

Locations (1)

Wei Liu; 🇨🇳 Wuhan, Hubei, China