Comparison of the therapeutic effect of Ursodeoxycholic acid and Synbiotic versus isolated phototherapy on indirect hyperbilirubinemia.

Phase 3

Recruiting

Conditions: Neonatal jaundice due to excessive hemolysis, unspecified
Indirect Hyperbilirubinemia (Neonatal jaundice).

Registration Number: IRCT20181006041252N9

Lead Sponsor: Sabzevar University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 120

Inclusion Criteria

Infants aged 2 to 14 days.
Infants with a serum bilirubin level between 14 and 25 mg/dl and direct bilirubin of less than 2 mg/dl.
Infants with reticulocyte count in normal range.
Infants with no Hematoma cerebral and Caput succedaneum.
Infants with gestational age greater than 37 weeks.
Infants with birth weight more than 2500 grams.
Infants without polycythemia (hematocrit over 65).
Infants without underlying illness.
Infants without exchange transfusion.

Exclusion Criteria

Infants with low hemoglobin and positive glucose 6-phosphate dehydrogenase enzyme and Coombs tests.
Infants who receive serum therapy, antibiotic therapy, and IV immunoglobulin (IVIG).
Infants with abnormal peripheral blood smear tests.
Infants with septicemia, Crigler–Najjar syndrome, thyroid and liver diseases.
Infants from diabetic mother.
Infants with direct hyperbilirubinemia, blood type incompatibility, and RH.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total bilirubin. Timepoint: At the beginning of the study (before the intervention), 12, 24 and 48 hours after starting the intervention. Method of measurement: Flame photometry device.

Secondary Outcome Measures