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Ursodeoxycholic Acid Prevents Total Parenteral Nutrition Cholestasis

China80 participantsStarted 2021-01-01

Plain-language 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.

Who can participate

Age range1 Day – 28 Years

SexALL

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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

What they're measuring

direct bilirubin value of participants

Timeframe: up to 10 weeks

Trial details

NCT IDNCT05043194

SponsorWei Liu

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-09-30

View on ClinicalTrials.gov More Cholestasis of Parenteral Nutrition trials