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Effect of ursodeoxycholic acid on breast milk jaundice

A prospective study on the effect of ursodeoxycholic acid on breast milk jaundice in neonate

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2017013028154N1
Enrollment
80
Registered
2017-06-11
Start date
2017-02-03
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Breast milk jaundice. Neonatal jaundice from breast milk inhibitor

Interventions

Intervention 1: Intervention group: Intervention group includes 40 neonates with breast milk jaundice that treat with phototherapy (home or hospital) and URSODEOXYCHOLIC ACID 10 mg/kg/day (CAPSULE OR
Treatment - Drugs
Placebo
Intervention group: Intervention group includes 40 neonates with breast milk jaundice that treat with phototherapy (home or hospital) and URSODEOXYCHOLIC ACID 10 mg/kg/day (CAPSULE ORAL 300 mg) oral
Control group: The control groups include 40 infants who receiving placebo (distilled water) and phototherapy (home or hospital). Total bilirubin level is measured 12, 24 and 48 hours after photother

Sponsors

Vice chancellor for research of Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
7 Days to 1 Months

Inclusion criteria

Inclusion criteria: Inclusion criteria: birth weights 2500 to 4000 gram; being exclusively breastfed; gestational age of 38 to 41 weeks; age more than 7 days old; total bilirubin level of 14 to 20 mg/dL; direct bilirubin level less than 2 mg/dL. Exclusion criteria: infants with ABO and RH incompatibility; glucose 6-phosphate dehydrogenase deficiency; direct hyperbilirubinemia; septicemia; diseases leading to hyperbilirubinemia (Crigler-Najjar syndrome, gilbert syndrome, hypothyroidism and hyperthyroidism, liver diseases, premature neonates and the infants of diabetic mothers)

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Total bilirubin level. Timepoint: Before intervention, 12, 24 and 48 hours after intervention. Method of measurement: mg/dl.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Nasri Lari

Shiraz University of Medical Sciences

maryamnasri2000@yahoo.com+98 917 700 0045

Outcome results

None listed

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