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Ursodeoxycholic Acid Prevents Total Parenteral Nutrition Cholestasis (UDACPPNAC)

Primary Purpose

Cholestasis of Parenteral Nutrition

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Ursodeoxycholic Acid 250 Mg Oral Capsule
Sponsored by
Wei Liu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cholestasis of Parenteral Nutrition

Eligibility Criteria

1 Day - 28 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Wei LiuRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

ursodeoxycholic acid arm

the control arm

Arm 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 .

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 .

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 1, 2021
Last Updated
September 13, 2021
Sponsor
Wei Liu
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1. Study Identification

Unique Protocol Identification Number
NCT05043194
Brief Title
Ursodeoxycholic Acid Prevents Total Parenteral Nutrition Cholestasis
Acronym
UDACPPNAC
Official Title
The Preventive Study of Ursodeoxycholic Acid(UDCA) on Total Parenteral Nutrition Cholestasis(PNAC) in Premature Infants
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
September 30, 2021 (Anticipated)
Study Completion Date
July 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Wei Liu

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholestasis of Parenteral Nutrition

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ursodeoxycholic acid arm
Arm Type
Experimental
Arm 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 .
Arm Title
the control arm
Arm Type
Sham Comparator
Arm 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 .
Intervention Type
Drug
Intervention Name(s)
Ursodeoxycholic Acid 250 Mg Oral Capsule
Intervention Description
prevention
Primary Outcome Measure Information:
Title
direct bilirubin value of participants
Description
Weekly direct bilirubin values in μmol/L for preterm infants during hospitalization will be collected to assess the severity of cholestasis
Time Frame
up to 10 weeks
Secondary Outcome Measure Information:
Title
The γ-GT activity level of participants
Description
Weekly γ-GT values in U/L for preterm infants during hospitalization will be collected to assess the severity of cholestasis
Time Frame
up to 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
28 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
liwen chang
Organizational Affiliation
Tongji Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wei Liu
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
wei liu, doctor
Phone
027-83663332
Email
liuweistudy@126.com
First Name & Middle Initial & Last Name & Degree
siying liu, master
Phone
027-83663332
Email
liusiying5200527@qq.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Ursodeoxycholic Acid Prevents Total Parenteral Nutrition Cholestasis

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