Effect of Ursodeoxycholic Acid on Indirect Hyperbilirubinemia in Neonates Treated With Phototherapy

NCT07867366 | Completed

• 1 other identifier: Dr-Nusrat-DGK
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

There is limited local data on the efficacy of ursodeoxycholic acid combined with phototherapy. Therefore, the present study was planned to compare mean serum bilirubin levels in neonates with indirect hyperbilirubinemia receiving phototherapy alone with those receiving combination treatment with phototherapy and ursodeoxycholic acid.

Conditions

Hyperbilirubinemia Indirect

Outcome Measures

Primary Outcomes (1)

• Mean serum bilirubin level

  Mean serum bilirubin level measured 48 hours after initiation of treatment were compared between neonates receiving phototherapy alone and those receiving phototherapy combined with ursodeoxycholic acid.

  48 hours after initiation of treatment

Study Arms (2)

Phototherapy-Group

EXPERIMENTAL

Patients received phototherapy and placebo.

Other: Phototherapy with placebo

Ursodeoxycholic acid-Group

EXPERIMENTAL

Patients received phototherapy along with ursodeoxycholic acid in a dose of 10mg/kg body weight/day.

Drug: Phototherapy with ursodeoxycholic acid

Interventions

Phototherapy with placebo OTHER

Patients received phototherapy and placebo.

Phototherapy-Group

Phototherapy with ursodeoxycholic acid DRUG

Patients received phototherapy along with ursodeoxycholic acid in a dose of 10mg/kg body weight/day.

Ursodeoxycholic acid-Group

Eligibility Criteria

• Age: 3 Days - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Neonates of either sex
• Age 3-28 days
• Gestational age 38-41 weeks
• Birth weight 2.5-4.0 kg
• Total serum bilirubin level 14-20 mg/dL and direct bilirubin level \<2 mg/dL

You may not qualify if:

• Neonates with ABO incompatibility or Rhesus (Rh) incompatibility
• Glucose-6-phosphate dehydrogenase (G6PD) deficiency
• Septicemia
• Conditions causing hyperbilirubinemia, including Crigler-Najjar syndrome, Gilbert syndrome, hypothyroidism, hyperthyroidism, or liver disease
• Infants of diabetic mothers
• Major congenital anomalies
• Previous exposure to phototherapy

Sponsors & Collaborators

• Muhammad Aamir Latif: lead

Study Sites (1)

Allama Iqbal Teaching Hospital/D.G. Khan Medical College

Dera Ghazi Khan, Punjab Province, 32200, Pakistan

Location

MeSH Terms

Interventions

Phototherapy; Ursodeoxycholic Acid

Intervention Hierarchy (Ancestors)

Therapeutics; Deoxycholic Acid; Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes

Study Officials

• Nusrat Hussain, FCPS

  Allama Iqbal Teaching Hospital/D. G. Khan Medical College

  PRINCIPAL INVESTIGATOR

• Ayaz Ali, FCPS

  Allama Iqbal Teaching Hospital/DG Khan Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Consultant

Study Record Dates

• First Submitted: October 5, 2026
• First Posted: October 9, 2026
• Study Start: February 1, 2026
• Primary Completion: July 31, 2026
• Study Completion: July 31, 2026
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)