Ursodeoxycholic Acid Prevents Total Parenteral Nutrition Cholestasis

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Preventive Study of Ursodeoxycholic Acid(UDCA) on Total Parenteral Nutrition Cholestasis(PNAC) in Premature Infants

Conditions
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Cholestasis of Parenteral Nutrition

Intervention / Treatment
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* Drug: Ursodeoxycholic Acid 250 Mg Oral Capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: admission to the hospital within 24 hours after birth gestational ages:28-32 weeks requiring TPN during the first days of life Exclusion Criteria: major congenital abnormalities, chromosomal abnormality congenital intrauterine infection, genetic metabolic diseases structural liver abnormality surgical treatment was taken during hospitalization with severe symptoms of digestive system disease before TPN incompletion or withdrawal of treatment during hospitalization

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 28 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ursodeoxycholic acid arm<br>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 . | Drug: Ursodeoxycholic Acid 250 Mg Oral Capsule<br>* prevention<br>|
| Sham Comparator: the control arm<br>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 . | Drug: Ursodeoxycholic Acid 250 Mg Oral Capsule<br>* prevention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | up to 10 weeks |