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efficacy of ursodeoxycholic plus phototherapy in the treatment of neonatal jaundice

A comparative study on efficacy of ursodeoxycholic plus phototherapy with single phototherapy in the treatment of indirect hyperbilirubinemia of neonates

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
IRCT
Registry ID
IRCT201611163127N3
Enrollment
100
Registered
2016-12-31
Start date
2015-03-20
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

Neonatal jaundice. Neonatal jaundice due to other excessive haemolysis, Neonatal jaundice from other and unspecified causes

Interventions

Intervention 1: Intervention Group: Phototherapy (with 8-lamp Phototherapy unit made by Tousan Company
Tehran, Iran) along with 10 mg/kg/day divided q12h ursodeoxycholic acid (made by Dr. Adidbi Company
Tehran, Iran). The intervention for each patient will start since him/her hospitalization and will continue until him/her total bilirubin level reaches below 10mg/dL. Intervention 2: Control Group: Ph
Tehran, Iran) along with water as placebo. The intervention for each patient will start since him/her hospitalization and will continue until him/her total bilirubin level reaches below 10mg/dL.
Treatment - Drugs
Placebo
Intervention Group: Phototherapy (with 8-lamp Phototherapy unit made by Tousan Company
Tehran, Iran). The intervention for each patient will start since him/her hospitalization and will continue until him/her total bilirubin level reaches below 10mg/dL.
Control Group: Phototherapy (with 8-lamp Phototherapy unit made by Tousan Company
Tehran, Iran) along with water as placebo. The intervention for each patient will start since him/her hospitalization and will continue until him/her total bilirubin level reaches below 10mg/dL.

Sponsors

Vice chancellor for research, Ardabil University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Days to 28 Days

Inclusion criteria

Inclusion criteria: Inclusion criteria: Birth weight between 2500 to 4000 g; Only breastfeeding; Gestational age between 38 to 41 weeks; Older than 3 days, total bilirubin between 14 to 20 mg/dL; direct bilirubin less than 2 mg/dL. Exclusion criteria: ABO and RH incompatibility; G6PD Deficiency; Direct hyperbilirubinemia; Septicemia; diseases leading to hyperbilirubinemia (including Crigler-Najjar syndrome, Gilbert's syndrome, hypothyroidism / hyperthyroidism, liver diseases, and ....); Premature infants; Newborns of diabetic mothers.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Total bilirubin. Timepoint: on admission and every 12 hours after admission until discharge. Method of measurement: Blood sampling.;Time duration in which bilirubin levels reaches to normal level. Timepoint: Continuously (from treatment beginning until bilirubin reach to normal levels). Method of measurement: Timer.

Secondary

MeasureTime frame
-. Timepoint: -. Method of measurement: -.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShima Sarfarazi

Ardabil University of Medical Sciences

sh.sarfarazi@gmail.com+98 45 3373 1210

Outcome results

None listed

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