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

Investigating the effect of Ursodeoxycholic acid and Synbiotic versus isolated phototherapy on indirect hyperbilirubinemia in hospitalized neonates under phototherapy.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20181006041252N9
Enrollment
120
Registered
2019-01-26
Start date
2019-01-30
Completion date
Unknown
Last updated
2019-02-25

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

Conditions

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

Interventions

Intervention 1: First intervention group: Patients in this group are treated with Ursodoxicillic acid (Alborzdarou Pharmaceutical Company) 10 mg/kg daily with phototherapy for two days. Intervention 2

Sponsors

Sabzevar University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Days to 14 Days

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public Contact?Dr. Mitra Aldaghi

Sabzevar University of Medical Sciences

Aldaghim@medsab.ac.ir+98 51 4401 1604

Outcome results

None listed

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