The effect of Ursodeoxycholic Acid on neonatal jaundice

Evaluating the Effect of Ursodeoxycholic Acid on total bilirubin of neonate with neonatal indirect hyperbilirubinemia who have Glucose-6-phosphate dehydrogenase deficiency compare to control group

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190604043813N2

Enrollment

Registered

2020-03-31

Start date

2020-04-20

Completion date

Unknown

Last updated

2020-04-21

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

Conditions

Neonatal indirect hyperbilirubinemia. Neonatal jaundice from other specified causes

Interventions

Intervention 1: Intervention group: The intervention group will receive oral drug of Ursodeoxycholic acid (UDCA) 10 mg/kg (2cc/kg) daily divided into 2 doses every 12 hours. Dr. Obidi's 300 mg capsule

Eligibility

Sex/Gender

All

Age

1 Days to 10 Days

Inclusion criteria

Inclusion criteria: Exclusive breastfeeding, Total bilirubin levels above 14 mg / dL and below 20 mg / dL, Direct bilirubin levels below 2 mg / dL. Age above 1 day Glucose 6 phosphate dehydrogenase deficiency Parent consent

Exclusion criteria

Exclusion criteria: Infection and septicemia Uunderlying disease such as heart and liver disease The diabetic mother Rh incompatibility

Design outcomes

Primary

Measure	Time frame
Total bilirubin. Timepoint: Every 24 hours until total bilirubin fall bellow 10 mg/dl. Method of measurement: Total bilirubin is measured by the diazo method.	—

Secondary

Measure	Time frame
Median admission time. Timepoint: Once. Method of measurement: The number of hospitalization days.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHourvash Akbari Haghighinejad

Shiraz University of Medical Sciences

hhaghighi@sums.ac.ir00897136474967

Outcome results

None listed

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