Therapeutic effect of oral ursodeoxycholic acid on indirect hyperbilirubinemia in full-term neonates undergoing phototherapy in hospital 17 Shahrivar - a randomized controlled clinical trial

Phase 3

• Conditions: Hyperbilirubinemia.; Other disorders of bilirubin metabolism; E80.6

• Registration Number: IRCT20210201050199N1
• Lead Sponsor: Rasht University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 April 2021

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

Parents' complete satisfaction with the presence of children in the study
Birth weight 2500 to 4000 grams
Exclusive breastfeeding,
Gestational age 38 to 41 weeks
Age 3 to 7 days
Total bilirubin 14 to 20 and direct bilirubin less than 2

Exclusion Criteria

ABO and RH incompatibility
G6PD enzyme deficiency
Direct hyperbilirubinemia
Septicemia
Diseases leading to hyperbilirubinemia (carpenter Kriegler syndrome, Gilbert syndrome, hyperthyroidism, hypothyroidism, liver disease)
Preterm
Neonate of mothers with gestational diabetes mellitus

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total bilirubin. Timepoint: Every 24 hours. Method of measurement: Autoanalyzer device.

Secondary Outcome Measures

Name	Time	Method
Indirect bilirubin. Timepoint: Every 24 hours. Method of measurement: Autoanalyzer device.