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effectiveness of Ursodeoxycholic acid in prevention of cholestasis caused by total parenteral nutrition

Investigating the effectiveness of Ursodeoxycholic acid in preventing cholestasis in neonates and infants hospitalized in NICU treated with total parenteral nutrition (TPN)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20241123063815N1
Enrollment
64
Registered
2024-11-28
Start date
2024-11-25
Completion date
Unknown
Last updated
2025-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal cholestasis following total parenteral nutrition. Toxic liver disease, unspecified

Interventions

Intervention 1: Intervention group: TPN+ UDCA (20 mg/kg per day divided into three daily doses) in the intervention group UDCA 20 mg/kg per day (solution prepared with a concentration of 30 mg/ml from

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 1 Years

Inclusion criteria

Inclusion criteria: Having parental consent to participate in the study Having an indication for TPN (prematurity (children) and NEC, gastroschisis, severe jejunoileal atresia, loss equal to or greater than 50% of expected small bowel length for gestational age at surgery) total parenteral nutrition for more than two weeks Primary serum conjugated bilirubin less than 2 mg/dl Negative diagnostic test for other possible causes of conjugated hyperbilirubinemia Newborns and infants admitted to the NICU

Exclusion criteria

Exclusion criteria: Patients with lack of parental consent to participate in the study Patients with multiple congenital malformations, life-threatening renal or cardiovascular disease, evidence of biliary tract abnormalities, or evidence of other forms of cholestatic liver disease

Design outcomes

Primary

MeasureTime frame
Cholestasis (Primary serum conjugated bilirubin greater than 2 mg/dl). Timepoint: Time periods before receiving the drug, 3 days later, 1 week later, 2 weeks later, 3 weeks later and 4 weeks after receiving the drug. Method of measurement: Bilirubin test laboratory kit.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammadreza Mollaabbasi

Shahid Beheshti University of Medical Sciences

mrmollaabbasi@gmail.com+98 35 3525 6344

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026