Ursodeoxycholic Acid Prevents Total Parenteral Nutrition Cholestasis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-07-30

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.

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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.

Conditions

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Cholestasis of Parenteral Nutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ursodeoxycholic acid arm

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 .

Group Type EXPERIMENTAL

Ursodeoxycholic Acid 250 Mg Oral Capsule

Intervention Type DRUG

prevention

the control arm

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 .

Group Type SHAM_COMPARATOR

Ursodeoxycholic Acid 250 Mg Oral Capsule

Intervention Type DRUG

prevention

Interventions

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Ursodeoxycholic Acid 250 Mg Oral Capsule

prevention

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

1 Day

Maximum Eligible Age

28 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No