Completed

Randomized Study of Tauroursodeoxycholic Acid in Prophylactic Therapy of Total Parenteral Nutrition Associated Cholestasis in Infants

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What is being tested

tauroursodeoxycholic acid

Drug
Who is being recruted

Bile Duct Diseases+6

+ Biliary Tract Diseases

+ Digestive System Diseases

See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: June 1998
See protocol details

Summary

Principal SponsorChildren's Hospital Medical Center, Cincinnati
Last updated: March 25, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 1998

Actual date on which the first participant was enrolled.

PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by birth weight. Patients are randomized in pairs by birth weight to receive either a placebo in arm I or tauroursodeoxycholic acid (TUDCA) in arm II. TUDCA is administered by mouth, nasogastric tube, or gastrostomy tube twice daily. After 2 weeks of therapy, a bile sample is obtained via a duodenal tube. An ultrasound examination of the liver and biliary tract is performed after 2 weeks and every 3 weeks thereafter until discontinuation of therapy or until presence of biliary tract sludge is noted on 2 consecutive examinations. Completion date provided represents the completion date of the grant per OOPD records

NCT00004410
Principal SponsorChildren's Hospital Medical Center, Cincinnati
Last updated: March 25, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

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

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDisease AttributesCholestasisGastrointestinal DiseasesRare Diseases

Criteria

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Hospitalized infants who are anticipated to require total parenteral nutrition for greater than 2 weeks and have: Major gastrointestinal anomalies (gastroschisis, ruptured omphalocele) OR Resection (necrotizing enterocolitis, volvulus) No evidence of biliary tract abnormalities No evidence of other forms of cholestatic liver disease --Patient Characteristics-- Renal: No life threatening renal disease Cardiovascular: No life threatening cardiovascular disease Other: No multiple congenital abnormalities

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Children's Hospitals and Clinics - Minneapolis

Minneapolis, United StatesOpen Children's Hospitals and Clinics - Minneapolis in Google Maps

University of Mississippi Medical Center

Jackson, United States

Children's Hospital Medical Center - Cincinnati

Cincinnati, United States
Completed3 Study Centers