Efficacy of Ursodeoxycholic acid in the treatment of indirect hyperbilirubinemia in neonates
Phase 3
Recruiting
- Conditions
- Indirect Hyperbilirubinemia.Neonatal jaundice due to excessive hemolysis, unspecified
- Registration Number
- IRCT20170719035178N2
- Lead Sponsor
- Sabzevar University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 88
Inclusion Criteria
Birth weight more than 2500 gr
Gestational age more than 37 weeks
The birthday more than 2 days and less than two weeks
The total bilirubin level is 14-20 mg/dl and the direct bilirubin level is less than 2 mg/dl
No Septicemia
lack of Crigler–Najjar syndrome
lack of Thyroid disease
lack of Liver disease
lack of direct hyperbilirubinemai
Incompatibility of blood groups and RH
lack of G6PD deficiency
Infants aged 2 to 14 days
Exclusion Criteria
Parental dissatisfaction for any reason
The incidence of any side effects of Ursodeoxycholic acid
Infants from diabetic mother
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total bilirubin. Timepoint: The time intervals for measuring total bilirubin levels are at the baseline (before the intervention), 12, 24, and 36 hours after starting treatment (phototherapy with or without Ursobil). Method of measurement: Autoanalyzer devices.
- Secondary Outcome Measures
Name Time Method Drug side effects. Timepoint: During the intervention at 12, 24, and 36 hours after intervention. Method of measurement: Clinical evaluation.