Ursodeoxycholic Acid Prevents Total Parenteral Nutrition Cholestasis (UDACPPNAC)

Wei Liu

Status: Unknown

Conditions: Cholestasis of Parenteral Nutrition

Treatments: Drug: Ursodeoxycholic Acid 250 Mg Oral Capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT05043194

wei liu

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 1 day to 28 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups

ursodeoxycholic acid arm

Experimental group

Description:

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 .

Treatment:

Drug: Ursodeoxycholic Acid 250 Mg Oral Capsule

the control arm

Sham Comparator group

Description:

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 .

Treatment:

Drug: Ursodeoxycholic Acid 250 Mg Oral Capsule