Investigation of the effect of oral ursodeoxycholic acid drug in neonatal jaundice

Comparison of the effect of adding oral ursodeoxycholic acid to phototherapy and phototherapy alone on indirect hyperbilirubinemia in term infants with G6PDd and ABO and Rh incompatibility - a randomized controlled clinical trial study

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

IRCT

Registry ID

IRCT20130313012803N3

Enrollment

106

Registered

2023-12-02

Start date

2023-12-06

Completion date

Unknown

Last updated

2024-01-22

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

Conditions

Infant hyperbilirubinemia. Disorders of porphyrin and bilirubin metabolism

Interventions

Intervention 1: Intervention group: 3 to 10-day term infants with indirect hyperbilirubinemia with G6PDd and ABO and Rh incompatibility who receive ursodeoxycholic acid at a dose of 10 mg per kilogram

Eligibility

Sex/Gender

All

Age

3 Days to 10 Days

Inclusion criteria

Inclusion criteria: parents' complete satisfaction with the presence of infants in the study infants aged 3 to 10 days birth weight: 2500 to 4000 grams exclusive breastfeeding gestational age: 37 to 41 weeks total bilirubin 14 to 20 and direct is less than 1 mg/dl

Exclusion criteria

Exclusion criteria: history of any neurological disease children with a history of seizures electrolyte imbalance related to chronic disease (measured by blood test), direct hyperbilirubinemia (measured by blood test) septicemia, diseases leading to hyperbilirubinemia (Crigler-Najjar syndrome, Gilbert syndrome, hyperthyroid, hypothyroid, liver diseases) babies with jaundice without ABO and Rh incompatibility and G6PDD receiving IVIG preterm infants babies of diabetic mothers obstruction of the bile ducts babies who have 2 or more of the mentioned risk factors at once

Design outcomes

Primary

Measure	Time frame
Bilirubin level. Timepoint: The studied infants are checked for hyperbilirubinemia upon arrival and then at least once every 12-24 hours with a serum sample. Method of measurement: BT3500 device and photometric method using 2 and 4 dichloroaniline (DCA).	—

Secondary

Measure	Time frame
Duration of hospitalization. Timepoint: During the period of hospitalization of the infant, the pediatric resident visits her every 8 hours and examines her for possible complications. Method of measurement: Examination by the pediatric resident.;Drug side effects. Timepoint: During the period of hospitalization of the infant, the pediatric resident visits her every 8 hours and examines her for possible complications. Method of measurement: Examination by the pediatric resident.	—

Measure

Time frame

Duration of hospitalization. Timepoint: During the period of hospitalization of the infant, the pediatric resident visits her every 8 hours and examines her for possible complications. Method of measurement: Examination by the pediatric resident.;Drug side effects. Timepoint: During the period of hospitalization of the infant, the pediatric resident visits her every 8 hours and examines her for possible complications. Method of measurement: Examination by the pediatric resident.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Sadruddin Mehdipour

Rasht University of Medical Sciences

Smb1355@gmail.com+98 13 3336 9002

Outcome results

None listed

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