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IRCT20260802070508N1 IRCT 2026-10-30 Birjand University of Medical Sciences Evaluation of Oral Calcium Gluconate Effect on Serum Bilirubin Levels in Late Preterm Neonates Admitted to the Neonatal Intensive Care Unit of Vali-Asr Hospital in 2026 Evaluation of Oral Calcium Gluconate Effect on Serum Bilirubin Levels in Late Preterm Neonates Admitted to the Neonatal Intensive Care Unit of Vali-Asr Hospital in 2026 2026-11-22 anticipated 62 Pending https://irct.ir/trial/92381 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization will be employed for participant allocation. This method is used to ensure a relative balance in the number of participants between the two groups throughout the enrollment process. Generation of Random Numbers and Group Allocation: 1. Block Size Determination: The block size will be predefined; in this study, a block size of four will be used. This means that within each block, four neonates will be randomly allocated to the two groups. 2. Generation of Permutation Blocks: For each block, all possible permutations of participant allocation to the groups will be generated (in this case, two participants in the intervention group and two in the control group). For a block size of four, the possible permutations are: AABB, ABAB, ABBA, BAAB, BABA, and BBAA (A: intervention group; B: control group). 3. Random Selection of Blocks: The permutation blocks will be randomly selected, and their sequence will also be randomized. For example, a possible random sequence may be: BABA, AABB, BBAA, ABAB, and so on. 4. Participant Allocation: As each eligible neonate is enrolled, allocation will be performed according to the predefined randomized block sequence. For example, the first neonate may be assigned to group B (control), the second to group A (intervention), the third to group B, and the fourth to group A. Upon completion of the first block, allocation will proceed with the next randomly ordered block. 5. Use of Software or Random Number Tables: The generation of random blocks and participant allocation will be conducted using statistical software (such as R, Stata, or Excel) or standard random number tables with a predefined algorithm to ensure complete allocation concealment and minimize selection bias, Blinding description: Given the nature of the intervention, namely the oral administration of calcium gluconate, which is readily identifiable, complete double blinding of the patients and the clinical care team directly involved in the management of the neonates will not be feasible. However, to the extent possible, the researchers responsible for statistical data analysis will remain blinded to the allocation of neonates to the intervention and control groups (single blinding). This will be achieved by coding the data and separating group allocation information from the primary dataset to minimize potential bias in the analysis of the results. Since the study outcomes will be assessed using quantitative and standardized methods, the absence of complete blinding is not expected to result in substantial bias. 3 Indirect (unconjugated) hyperbilirubinemia. Intervention 1: Intervention group: The intervention group consists of 31 late preterm neonates with jaundice (icterus) who, in addition to standard treatment (phototherapy), will receive oral calcium gluconate at a dose of 50 mg per kg of body weight per day, divided into four equal doses. Intervention 2: Control group: The control group consisted of 31 late preterm neonates with jaundice who received standard treatment for unconjugated hyperbilirubinemia (phototherapy). Yes - There is a plan to make this available What will be shared: This dataset includes demographic data, laboratory results (total and direct bilirubin, total calcium, albumin, CBC, blood group, direct Coombs test, reticulocyte count, G6PD assay, and peripheral blood smear) at baseline, 12, 24, 48, and 72 hours, as well as the final assessment, total duration of phototherapy, and information on possible adverse events. The data are provided in anonymized form after coding and removal of direct identifiers (name, medical record number, etc.). When: Data will be available starting 6 months after the publication of the final article resulting from this study and will remain accessible for a period of 5 years. To whom: Access is restricted to researchers affiliated with recognized academic institutions, research centers, and scientific organizations who submit a written and justified request. Conditions: The data may be used solely for scientific research purposes, including verification of the original study results, meta-analyses, or secondary analyses related to neonatal hyperbilirubinemia and the effect of calcium supplementation. Commercial use, redistribution of the raw data without prior written permission from the principal investigator, and any attempt to re-identify participants are strictly prohibited. Where to obtain: Contact by phone or submit a written request via email to the Vice-Chancellor for Research of Birjand University of Medical Sciences: Email: research@bums.ac.ir Phone: 056-32381200 How to obtain: The applicant submits a written request, including an explanation of the research purpose, their full personal details, and institutional affiliation, via email to the Vice-Chancellor for Research of Birjand University of Medical Sciences. After reviewing the reason for the data access request, the data will be provided to the researcher. Comments:
public Gholamreza Faal
Valiasr Hospital, Ghaffari Blvd., Birjand, Iran
Birjand Iran (Islamic Republic of) 9717964151 +98 56 3162 2221 grfal159@gmail.com Birjand University of Medical Sciences scientific Gholamreza Faal
Valiasr Hospital, Ghaffari Blvd., Birjand, Iran
Birjand Iran (Islamic Republic of) 9717964151 009831622221 grfal159@gmail.com Birjand University of Medical Sciences Iran (Islamic Republic of) Late preterm neonates (34–36 weeks and 6 days of gestation) diagnosed with indirect hyperbilirubinemia requiring phototherapy, who meet all of the following conditions:Absence of clinical instability No evidence of sepsis Not currently intubated No clinical or laboratory evidence of infection or hemolysis No contraindication to oral medication (not NPO) No prior treatment with calcium before initiation of phototherapy (for hypocalcemia or total parenteral nutrition) Serum calcium level ≤10 mg/dL at the time of initiation of phototherapy No maternal history of opioid addiction No maternal use of anticonvulsant medications No maternal hyperparathyroidism Absence of any congenital anomalies Parental consent for participation in the study no limit 30 days Both Unstable clinical condition Sepsis Intubation Clinical or laboratory evidence of infection or hemolysis Contraindication to oral medication Calcium therapy before initiation of phototherapy due to hypocalcemia or total parenteral nutrition (TPN) Serum calcium level >10 mg/dL at the initiation of phototherapy Maternal opioid addiction Maternal use of anticonvulsant medications Maternal hyperparathyroidism Presence of any congenital anomaly Parental refusal to participate in the study P59.0 Neonatal jaundice associated with preterm delivery Treatment - Drugs Treatment - Devices Intervention group: The intervention group consists of 31 late preterm neonates with jaundice (icterus) who, in addition to standard treatment (phototherapy), will receive oral calcium gluconate at a dose of 50 mg per kg of body weight per day, divided into four equal doses. Control group: The control group consisted of 31 late preterm neonates with jaundice who received standard treatment for unconjugated hyperbilirubinemia (phototherapy). Changes in serum levels of indirect (unconjugated) bilirubin. Timepoint: At baseline (admission),12, 24, 48, and 72 hours after the start of treatment, and at the final assessment. Method of measurement: Blood sample. Duration of phototherapy requirement. Timepoint: At baseline (admission),12, 24, 48, and 72 hours after the start of treatment, and at the final assessment. Method of measurement: Based on the serum bilirubin level until it decreases to 2 units below the phototherapy threshold. Serum calcium level. Timepoint: At baseline (admission), 12, 24, 48, and 72 hours after the start of treatment, and at the final assessment. Method of measurement: Blood sample. Rate of decrease in indirect (unconjugated) bilirubin. Timepoint: At baseline (admission), 12, 24, 48, and 72 hours after the start of treatment, and at the final assessment. Method of measurement: Blood sample. Birjand University of Medical Sciences Approved 2026-07-28 Ethics committee of Birjand University of Medical Sciences Birjand University of Medical Sciences, Ghaffari Blvd., Birjand, South Khorasan, Iran Birjand South Khorasan Iran (Islamic Republic of)