]>
IRCT20260915071065N2 IRCT 2026-11-07 Shiraz University of Medical Sciences Adjuvant Ursodeoxycholic Acid Therapy in Neonates Undergoing Phototherapy for Hyperbilirubinemia Adjuvant Ursodeoxycholic Acid Therapy in Neonates Undergoing Phototherapy for Hyperbilirubinemia: A Randomized Controlled Trial 2026-11-22 anticipated 268 Pending https://irct.ir/trial/93646 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Diagnostic, Randomization description: The random allocation sequence will be generated using a permuted block randomization method with blocks of four, ensuring an equal distribution of participants between the intervention and control groups. All six possible block combinations (ABAB, BABA, AABB, BBAA, ABBA, and BAAB) will be used. A table of random numbers will be employed to determine the order of these blocks and create the final allocation list for 268 participants (67 blocks in total), Blinding description: This study will be conducted as a single-blind trial. Due to the nature of the intervention, blinding of parents and the nursing staff administering the medication will not be feasible. However, the physician responsible for evaluating the outcomes will be blinded to group allocation to minimize assessment bias. In addition, the data analyst will also be blinded to the intervention groups during statistical analysis, using coded data to ensure objectivity. 1-2 Hyperbilirubinemia. Intervention 1: Intervention group: Oral UDCA 10 mg/kg every 12 hours plus intensive phototherapy. Intervention 2: Control group: Receive phototherapy alone. Yes - There is a plan to make this available What will be shared: Information regarding the primary outcome will be made available. Other data may be provided upon request in a de-identified format to protect patient confidentiality. When: Immediately after publication of the article. To whom: people working in academic institutions Conditions: Reputable academic institutions. The purpose and rationale for the data request will be reviewed at the time of the request, and access will be granted at the discretion of the investigators based on this assessment. Where to obtain: Requests must be submitted via email. Hamide Barzegar hamide.barzegar@gmail.com How to obtain: The rationale and purpose of the request must be provided via email. If the request is approved, the available data will be provided within 48 hours. Comments:
public Hamide Barzegar
Namazi Hospital, Namazi Square, Shiraz
Shiraz Iran (Islamic Republic of) 7193613311 +98 71 3612 5000 hamide.barzegar@gmail.com Shiraz University of Medical Sciences scientific Hamide Barzegar
Namazi Hospital, Namazi Square, Shiraz
Shiraz Iran (Islamic Republic of) 7193613311 +98 71 3612 5000 hamide.barzegar@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Age ≤30 days Gestational age ≥35 weeks Indirect hyperbilirubinemia requiring phototherapy Parental informed consent 1 day 30 days Both Hemodynamic instability Previous UDCA exposure Direct hyperbilirubinemia, Major congenital anomalies Severe liver disease Immediate need for exchange transfusion P59.9 Neonatal jaundice, unspecified Treatment - Drugs Treatment - Devices Intervention group: Oral UDCA 10 mg/kg every 12 hours plus intensive phototherapy. Control group: Receive phototherapy alone Duration of phototherapy until discharge (hours). Timepoint: 6,12 ,24 ,36 and 48 hours after starting treatment. Method of measurement: Capillary sampling. Need for exchange transfusion. Timepoint: 6,12 ,24 ,36 and 48 hours after starting treatment and comparing results with exchange transfusion chart. Method of measurement: Capillary sampling. Shiraz University of Medical Sciences Approved 2026-05-06 Ethics committee of Shiraz University of Medical Sciences Shiraz University of medical sciences, Zand street, Shiraz Shiraz Fars Iran (Islamic Republic of)