Ursodeoxycholic Acid Prevents Total Parenteral Nutrition Cholestasis

Wei Liu80 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Cholestasis of Parenteral Nutrition

Interventions

Ursodeoxycholic Acid 250 Mg Oral CapsuleDRUG

prevention

Eligibility

Sex: ALLMin age: 1 DayMax age: 28 Years

Medical Language ↔ Plain English

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

Locations (1)

Wei Liu

Wuhan, Hubei, China

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: up to 10 weeks

Secondary Outcomes

The γ-GT activity level of participants

Weekly γ-GT values in U/L for preterm infants during hospitalization will be collected to assess the severity of cholestasis

Time frame: up to 10 weeks

Data from ClinicalTrials.gov

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