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

Determining the Effect of Oral Calcium Gluconate on Serum Bilirubin Levels in Late Preterm Neonates Admitted to the Neonatal Intensive Care Unit of Valiasr Hospital

This study will be conducted as a single-blind, randomized, parallel-group clinical trial on 62 neonates (31 neonates in each of the intervention and control groups). Randomization will be performed using the Block Randomization method.

This study will be conducted on late preterm neonates admitted to the Neonatal Intensive Care Unit as a single-blind trial (with blinding of the researchers responsible for data analysis) involving 62 neonates (31 neonates in each group). the intervention group will receive oral calcium gluconate in addition to standard phototherapy.

Inclusion Criteria: Late preterm neonates with a gestational age of 34 to 36 weeks and 6 days who have indirect (unconjugated) hyperbilirubinemia and are admitted to the Neonatal Intensive Care Unit of Valiasr Hospital. Exclusion Criteria: Neonates who do not meet the inclusion criteria. In addition, any neonate who develops complications during the study will be withdrawn from the study.

All neonates enrolled in the study will receive standard phototherapy according to the hospital protocols under the supervision of a neonatologist. In addition to standard phototherapy, oral calcium gluconate will be administered at a dose of 50 mg/kg of body weight per day, divided into four equal doses (every 6 hours). The calcium gluconate ampoules will be prepared as a solution by the investigator and provided to the nursing staff for the purpose of this study. Administration will continue until the resolution of jaundice and discontinuation of phototherapy.

Serum indirect bilirubin level, Serum calcium level, Duration of phototherapy

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.

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.

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.).

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.

Access is restricted to researchers affiliated with recognized academic institutions, research centers, and scientific organizations who submit a written and justified request.

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.

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

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.