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Effect of oral Ursodeoxycholic acid on indirect jaundice of glucose-6-phosphate dehydrogenase-deficient neonates

Effect of oral Ursodeoxycholic acid with phototherapy on indirect hyperbilirubinemia in glucose-6-phosphate dehydrogenase-deficient neonates

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20091201002801N4
Enrollment
120
Registered
2019-06-15
Start date
2019-06-22
Completion date
Unknown
Last updated
2019-08-26

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

Conditions

Neonatal jaundice. Neonatal jaundice from other specified causes

Interventions

Intervention 1: Intervention group 1: Neonates receiving phototherapy and Ursodeoxycholic acid (10 mg / kg / day every 12 hours to 48 hours). Ursodeoxycholic acid is a 300 mg capsule manufactured by

Sponsors

Mazandaran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Days to 14 Days

Inclusion criteria

Inclusion criteria: Exclusive breast fed neonates Neonates with age of 2-14 days Direct bilirubin less than 15% of total serum billirubin or less than 1.5 mg/dl Neonates weighing between 2500 to 4000 grams. Neonates with jaundice and glucose 6-phosphate dehydrogenase deficiency require admission and phototherapy.

Exclusion criteria

Exclusion criteria: Neonates with sepsis diagnosis Blood group or Rh incompatibility between mother and neonate Direct hyperbilirubinemia Major congenital anomalies Need to exchange transfusion at the time of admission previous use of drugs like phenobarbital or cotoneaster History of previous exchange transfusion Previous phototherapy Infants of diabetic mother Spherocytosis or elliptocytosis in peripheral blood smear Evidence of severe hemolysis, Retic=5%

Design outcomes

Primary

MeasureTime frame
Mean total serum bilirubin level based on Mg/dl. Timepoint: 12, 24, 48 and 72 hours after intervention. Method of measurement: With the Diazo method and the kits of Tehran Pars ?Azmoon Co.

Secondary

MeasureTime frame
The percentage of total serum bilirubin reduction to the initial bilirubin. Timepoint: 24 hours after admission. Method of measurement: With the Diazo method and the kits of Tehran Pars Azmoon Co.;Duration of phototherapy. Timepoint: At discharge time. Method of measurement: Phototherapy's timer to hour.;Duration of admission. Timepoint: At discharge time. Method of measurement: Patient's file observation and documantation.;Duration of intensive phototherapy. Timepoint: At discharge time. Method of measurement: Patient's file observation and documantation.;Need to exchange. Timepoint: During admission. Method of measurement: Patient's file observation and documantation.;Need to re-hospitalization after discharge. Timepoint: 14 days of life. Method of measurement: Patient's file observation and documantation.;The necessary time in which, first total serum bilirubin level reaches to less than 10mg/d. Timepoint: During admission. Method of measurement: Patient's file observation and documantation.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactRoya Farhadi

Mazandaran University of Medical Sciences

rfarhadi@mazums.ac.ir+98 11 3334 3018

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 10, 2026