Effect of ursodeoxycholic acid in reducing hospitalization for phototherapy
Phase 3
- Conditions
- eonatal indirect hyperbilirubinemia.Neonatal jaundice from other and unspecified causes
- Registration Number
- IRCT20190604043813N4
- Lead Sponsor
- Shiraz University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 148
Inclusion Criteria
Exclusive breastfeeding,
Age above 1 day
Neonate born with gestational age 35 weeks or more
Total bilirubin between 3 mg / dL less than the level required for intensive phototherapy treatment in the hospital and the level required for hospitalization
Direct bilirubin levels below 2 mg / dL.
Parent consent
Infants whose parents agree not to use herbal or traditional medicines during the study period.
Exclusion Criteria
Rh incompatibility
Uunderlying disease such as heart and liver disease
Infection and septicemia
Neonate of diabetic mother
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hospitalization rate. Timepoint: Weekly, from week 1 to 4 after the start of the intervention. Method of measurement: Asking the parents about admission in hospital for phototherapy.
- Secondary Outcome Measures
Name Time Method Total bilirubin. Timepoint: Every 24 hours until the bilirubin reaches 3 mg / dl below the level required for intensive phototherapy. Method of measurement: Capillary method and diazo laboratory method.;Adverse effect of drug. Timepoint: Till 4 weeks after the start of the drug. Method of measurement: Asking the parents about adverse effect.