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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05043194
Other study ID # wei liu
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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