Cholestasis of Parenteral Nutrition Clinical Trial
— UDACPPNACOfficial title:
The Preventive Study of Ursodeoxycholic Acid(UDCA) on Total Parenteral Nutrition Cholestasis(PNAC) in Premature Infants
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 |
Verified date | September 2021 |
Source | Tongji Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
China | Wei Liu | Wuhan | Hubei |
Lead Sponsor | Collaborator |
---|---|
Wei Liu |
China,
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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