Cholestasis of Parenteral Nutrition
Conditions
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.
Interventions
prevention
Sponsors
Wei Liu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Days to 28 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Outcome results
None listed