EFFECTIVENESS OF ORAL METHYLPREDNISOLONE AS ADJUVANT THERAPY ON INFANTS WITH CHOLESTASIS IN DR SOETOMO GENERAL ACADEMIC HOSPITAL, SURABAYA, INDONESIA

EFFECTIVENESS OF ORAL METHYLPREDNISOLONE AS ADJUVANT THERAPY ON CLINICAL IMPROVEMENT, BIOCHEMICAL MARKERS, AND INFLAMMATION IN INFANTS WITH CHOLESTASIS

Status

Unknown

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20221026005

Enrollment

Registered

2022-10-26

Start date

2022-10-13

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Metylprednisolone in patients with cholestasis to improved the jaundice, liver function, and inflammation marker Cholestasis Infant Liver function Bilirubin Jaundice

Interventions

Metylprednisolone oral (generic) dose 2 mg/kg/day divided into 2 times a day for 14 days,Placebo

Experimental Drug,Placebo Comparator No treatment

Metylprednisolone,Placebo

Eligibility

Sex/Gender

All

Age

14 Days to 3 Months

Inclusion criteria

Inclusion criteria: 1. Suffered from cholestasis 2. Age : 14 days - 3 months old

Exclusion criteria

Exclusion criteria: 1. Suffering from congenital abnormalities 2. Suffering from genetic disorders 3. Suffering from severe infection/sepsis 4. Hemodynamic condition is unstable 5. Parents refuse to participate in research

Design outcomes

Primary

Measure	Time frame
Aspartate Transaminase Serum baseline and 14 days after intervention ELISA,Alanine Aminotransferase Serum baseline and 14 days after intervention ELISA,Bilirubin serum baseline and 14 days after intervention ELISA,Interferon alpha serum baseline and 14 days after intervention ELISA,Interleukine 4 serum baseline and 14 days after intervention ELISA,Interleukine 2 serum baseline and 14 days after intervention ELISA,Interleukine 6 serum baseline and 14 days after intervention ELISA,Interleukine 10 serum baseline and 14 days after intervention ELISA,TGF Beta 1 serum baseline and 14 days after intervention ELISA,ANCA serum baseline and 14 days after intervention ELISA	—

Measure

Time frame

Aspartate Transaminase Serum baseline and 14 days after intervention ELISA,Alanine Aminotransferase Serum baseline and 14 days after intervention ELISA,Bilirubin serum baseline and 14 days after intervention ELISA,Interferon alpha serum baseline and 14 days after intervention ELISA,Interleukine 4 serum baseline and 14 days after intervention ELISA,Interleukine 2 serum baseline and 14 days after intervention ELISA,Interleukine 6 serum baseline and 14 days after intervention ELISA,Interleukine 10 serum baseline and 14 days after intervention ELISA,TGF Beta 1 serum baseline and 14 days after intervention ELISA,ANCA serum baseline and 14 days after intervention ELISA

—

Secondary

Measure	Time frame
Stool colour baseline and 14 days after Stool colour card	—

Countries

Indonesia

Contacts

Public ContactBagus Setyoboedi

Airlangga University

bagus.setyoboedi@fk.unair.ac.id08123560043

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026