The Efficacy of Ursodeoxycholic Acid (UDCA) as Adjuvant Therapy to Phototherapy in the Management of Neonatal Indirect Hyperbilirubinemia
NCT ID: NCT07110987
Last Updated: 2025-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
70 participants
INTERVENTIONAL
2025-06-26
2027-03-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy & Safety of Oral Adjuvants to Phototherapy in Neonatal Hyperbilirubinemia
NCT06517862
Ursodeoxycholic Acid Prevents Total Parenteral Nutrition Cholestasis
NCT05043194
Randomized Study of Tauroursodeoxycholic Acid in Prophylactic Therapy of Total Parenteral Nutrition Associated Cholestasis in Infants
NCT00004410
Ursodeoxycholic Acid in the Treatment of Intrahepatic Cholestasis of Pregnancy
NCT01576458
Ursodiol for Treating Parenteral Nutrition Associated Cholestasis in Neonates
NCT00846963
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The study includes neonates ≥34 weeks gestational age and appropriate for gestational age (AGA), who meet the American Academy of Pediatrics (AAP) criteria for starting phototherapy.
Participants will be randomized 1:1 into two parallel arms:
Group A (Control): Continuous triple phototherapy
Group B (Intervention): Continuous triple phototherapy + oral UDCA at a dose of 10 mg/kg/day divided into two doses, using locally available Ursorasha (Rasha Pharma, license #1991/1192).
Randomization will be performed using stratified block randomization, with three stratification layers to balance known confounding factors across groups:
1. Hemolytic jaundice (ABO or Rh incompatibility)
2. Non-hemolytic jaundice (physiological or breast milk)
3. G6PD deficiency
Total serum bilirubin (TSB) will be monitored every 12 hours and compared across groups. Primary outcome is the time needed for bilirubin to drop below phototherapy threshold, according to age-specific AAP phototherapy nomograms.
Additional secondary analyses will include the rate of bilirubin decline at 24 and 48 hours, need for rescue therapy, and subgroup analysis based on gestational age (late preterm vs term), and jaundice type.
Based on retrospective hospital data, the anticipated enrollment is 70 neonates. However, due to the lower prevalence of G6PD deficiency, this subgroup may not yield enough cases for statistically powered subgroup analysis. It will instead be analyzed descriptively or as exploratory.
The study includes clearly defined inclusion/exclusion criteria and a unified therapeutic protocol applied to all infants.
Inclusion criteria: Neonates ≥34 weeks GA, AGA, with indirect hyperbilirubinemia requiring phototherapy.
Exclusion criteria: Neonates \<34 weeks, non-AGA, suspected/confirmed sepsis, TPN, liver disorders, or infants of diabetic mothers.
This protocol was initiated and registered within 21 days of enrolling the first patient. The study has received initial approval from the Department of Pediatrics at Lattakia University Hospital (formerly Tishreen University Hospital) under Committee Decision #70. Final administrative ethics approval from the university is in progress due to procedural delays in our country.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group A - phototherapy only
Infants who have indirect hyperbilirubinemia recieve continuous triple phototherapy only .
Phototherapy
Triple continuous phototherapy per AAP Guudelines
Group B - phototherapy + UDCA
Phototherapy + UDCA
Phototherapy
Triple continuous phototherapy per AAP Guudelines
ursodeoxycholic acid (UDCA)
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Phototherapy
Triple continuous phototherapy per AAP Guudelines
ursodeoxycholic acid (UDCA)
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Appropriate for Gestational Age (AGA) infants
3. Presence of indirect hyperbilirubinemia that meets the threshold for phototherapy.
Exclusion Criteria
2. Small or Large for Gestational Age
3. Direct (conjugated) hyperbilirubinemia \> 20% of total bilirubin
4. Suspected or confirmed sepsis
5. Neonates of diabetic mothers
6. Presence of congenital or acquired liver disease
7. Receiving Total Parenteral Nutrition (TPN)
1 Month
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tishreen University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ashraf Maan Alshelly
MD, Pediatric Resident
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Adnan H Dayoub, Prof.Neonat
Role: STUDY_DIRECTOR
Lattakia university hospital (Tishreen university Hospital ) , Lattakia university
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Lattakia University Hospital
Latakia, , Syria
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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
3. Hassan NM, El Said NM. Role of ursodeoxycholic acid in treatment of neonatal indirect hyperbilirubinemia. Iraqi J Pediatr. 2015;32(1):42-47.
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.
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.
Related Links
Access external resources that provide additional context or updates about the study.
PubMed - Meta-analysis on UDCA in neonates
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Alshelly-UDCA-2025
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.