Ursodeoxycholic Acid Prevents Total Parenteral Nutrition Cholestasis (UDACPPNAC)

September 13, 2021 updated by: Wei Liu

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 28 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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 .
Drug: Ursodeoxycholic Acid 250 Mg Oral Capsule
prevention
Sham Comparator: 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 .
Drug: Ursodeoxycholic Acid 250 Mg Oral Capsule
prevention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
direct bilirubin value of participants
Time Frame: 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
up to 10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The γ-GT activity level of participants
Time Frame: 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
up to 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wei Liu

Investigators

  • Principal Investigator: liwen chang, Tongji Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Anticipated)

September 30, 2021

Study Completion (Anticipated)

July 30, 2022

Study Registration Dates

First Submitted

September 1, 2021

First Submitted That Met QC Criteria

September 3, 2021

First Posted (Actual)

September 14, 2021

Study Record Updates

Last Update Posted (Actual)

September 20, 2021

Last Update Submitted That Met QC Criteria

September 13, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • wei liu

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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