The Efficacy of Ursodeoxycholic Acid (UDCA) as Adjuvant Therapy to Phototherapy in the Management of Neonatal Indirect Hyperbilirubinemia

NCT07110987 | Recruiting

• 1 other identifier: Alshelly-UDCA-2025
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, open-label, randomized controlled trial conducted at Lattakia University Hospital (Tishreen University), aiming to evaluate the efficacy of Ursodeoxycholic Acid (UDCA) as an adjuvant to triple phototherapy in the management of indirect hyperbilirubinemia in neonates ≥34 weeks of gestation. Eligible neonates will be randomly assigned to one of two groups: Group A: continuous triple phototherapy only Group B: UDCA (10 mg/kg/day in two oral doses) in addition to triple continuous phototherapy. Stratified randomization will be applied according to etiology (hemolytic, non-hemolytic, G6PD deficiency). The primary outcome is the rate and time of decline in total and indirect serum bilirubin to below phototherapy thresholds, monitored every 12 hours until discharge. This trial seeks to determine whether UDCA may reduce phototherapy duration or enhance bilirubin clearance in a safe and effective manner. Although this is an open-label trial for care providers and participants , the statstican conducting data analysis will be blinded to group allocation to reduce assessment bias.

Conditions

Hyperbilirubinemia, Neonatal Indirect

Keywords

Neonatal Jundice; Phototherapy; Ursodeoxycholic acid; UDCA; G6pd Deficiency; Rh incompatibilty; ABO incompatibility; Adjuvant therapy

Outcome Measures

Primary Outcomes (3)

• Reduction of total serum bilirubin to below phototherapy threshold

  Measurement of serum total bilirubin levels every 12 hours until they fall below the phototherapy threshold based on gestational age and postnatal age. Outcome is considered achieved once bilirubin levels drop below threshold and phototherapy can be discontinued .

  Day 0 to Day 7

• Time to bilirubin reduction below treatment threshold

  Time (in hours) from treatment initiation to TSB falling below phototherapy threshold in each group.

  Day 0 to Day 7

• Mean reduction in total serum bilirubin at 12 hours

  To compare the average decrease in total serum bilirubin after 12 hours between the two groups.

  12 hours of starting therapy

Secondary Outcomes (8)

• Comparison of Hospital stay between both groups

  Day 0 to Day 7

• Comparison of bilirubin reduction between late preterm (34weeks-36weeks+6 days) and term infants (≥37 weeks) in each treatment group.

  Up to 7 Days

• Comparison of bilirubin decline in each gestational age group (preterm vs preterm) and (term vs term) across jaundice types between treatment arms.

  Day 0 to Day 7.

• Need for retreatment

  Day 0 to Day 10 , Up to 3 days after treatment discontinuation.

• Incidence of adverse effects in the UDCA group

  Day 0 to Day 7

Study Arms (2)

Group A - phototherapy only

ACTIVE COMPARATOR

Infants who have indirect hyperbilirubinemia recieve continuous triple phototherapy only .

Procedure: Phototherapy

Group B - phototherapy + UDCA

EXPERIMENTAL

Phototherapy + UDCA

Procedure: Phototherapy; Drug: ursodeoxycholic acid (UDCA)

Interventions

Phototherapy PROCEDURE

Triple continuous phototherapy per AAP Guudelines

Also known as: Triple continuous phototherapy

Group A - phototherapy only; Group B - phototherapy + UDCA

ursodeoxycholic acid (UDCA) DRUG

10mg/kg/day orally divided in two doses (URSORASHA) . Given with feeds untill the bilirubin level drop down to limits that don't need therapy due to AAP guidelines.

Also known as: Ursodiol, UDCA

Group B - phototherapy + UDCA

Eligibility Criteria

• Age: Up to 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Neonates with gestational age ≥ 34 weeks
• Appropriate for Gestational Age (AGA) infants
• Presence of indirect hyperbilirubinemia that meets the threshold for phototherapy.

You may not qualify if:

• Gestational age \< 34 weeks
• Small or Large for Gestational Age
• Direct (conjugated) hyperbilirubinemia \> 20% of total bilirubin
• Suspected or confirmed sepsis
• Neonates of diabetic mothers
• Presence of congenital or acquired liver disease
• Receiving Total Parenteral Nutrition (TPN)

Sponsors & Collaborators

• Tishreen University Hospital: lead

Study Sites (1)

Lattakia University Hospital

Latakia, 0000, Syria

RECRUITING

Related Publications (5)

• Rodrigues CM, Steer CJ. The therapeutic effects of ursodeoxycholic acid as an anti-apoptotic agent. Expert Opin Investig Drugs. 2001 Jul;10(7):1243-53. doi: 10.1517/13543784.10.7.1243.

  PMID: 11772248 BACKGROUND

• 2. Wang H, et al. Effect of ursodeoxycholic acid on neonatal indirect hyperbilirubinemia: A meta-analysis. World J Pediatr. 2022;18(5):375-383. PMID: 35689782

  RESULT

• 3. Hassan NM, El Said NM. Role of ursodeoxycholic acid in treatment of neonatal indirect hyperbilirubinemia. Iraqi J Pediatr. 2015;32(1):42-47.

  RESULT

• Ughasoro MD, Adimorah GN, Chukwudi NK, Nnakenyi ID, Iloh KK, Udemba CE. Reductive effect of ursodeoxycholic acid on bilirubin levels in neonates on phototherapy. Clin Exp Gastroenterol. 2019 Jul 29;12:349-354. doi: 10.2147/CEG.S207523. eCollection 2019.

  PMID: 31534356 RESULT

• Rezaie M, Gholami R, Jafari M, Haghighinejad H. Evaluating the effect of ursodeoxycholic acid on total bilirubin of neonates with glucose-6-phosphate dehydrogenase deficiency complicated by indirect hyperbilirubinaemia. J Paediatr Child Health. 2021 Aug;57(8):1175-1181. doi: 10.1111/jpc.15411. Epub 2021 Mar 8.

  PMID: 33682983 RESULT

Related Links

• PubMed - Meta-analysis on UDCA in neonates

MeSH Terms

Conditions

Hyperbilirubinemia, Neonatal; Glucosephosphate Dehydrogenase Deficiency

Interventions

Phototherapy; Ursodeoxycholic Acid

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Genetic Diseases, Inborn; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Adnan H Dayoub, Prof.Neonat

  Lattakia university hospital (Tishreen university Hospital ) , Lattakia university

  STUDY DIRECTOR

Central Study Contacts

Ashraf M Alshelly, MD, Ped.Res.

CONTACT

+963930052903; Ashraf.m.alshelly@latakia-univ.edu.sy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Pediatric Resident

Study Record Dates

• First Submitted: July 13, 2025
• First Posted: August 8, 2025
• Study Start: June 26, 2025
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)