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IRCT20230914059430N1 IRCT 2024-01-29 Tehran University of Medical Sciences Investigating the simultaneous effect of Phototherapy with oral Zinc Sulfate on the amount of Bilirubin change in infants with Hyperbilirubinemia and the duration of their treatment in Baharlou Hospital. Investigating the effectiveness of Zinc Sulfate during the duration of the need for Phototherapy in infants with Congenital Jaundice 2024-02-20 anticipated 320 Complete https://irct.ir/trial/74930 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization of the study is done in groups of 4 babies in one box, and according to the 2 possible interventions, 6 modes are considered for these boxes, and the status of each box is determined by throwing a dice, Blinding description: The mentioned randomization is carried out by the researcher and also the solutions used in both interventions are similar in terms of color, smell and taste. 2 Congenital Jaundice. Intervention 1: Intervention group: Receiving oral zinc sulfate syrup 1 cc/kg, each cc containing 1 mg of zinc while performing phototherapy, which is checked for 48 hours. Intervention 2: Control group: Receiving a placebo of sucrose syrup with a concentration of 1cc/kg while performing phototherapy. Yes - There is a plan to make this available What will be shared: All potential data can be shared after de-identifying individuals after contacting the corresponding author. When: The beginning of the access period from 2026 To whom: Researchers, Doctors and Health Decision Makers Conditions: If any data is not reported in the text of the final report and the addressee needs it, this information will be provided to the requester if it is not about the confidential information of the patients. Where to obtain: The manager Dr. Ghorbani How to obtain: Contact the project manager Comments:
public Asghar Ghorbani
Keshavarz Blvd.
Tehran Iran (Islamic Republic of) 1417653761 +98 912 321 1189 aghorbani@sina.tums.ac.ir Tehran University of Medical Sciences scientific Asghar Ghorbani
Keshavarz Blvd.
Tehran Iran (Islamic Republic of) 1417653761 +98 912 321 1189 aghorbani@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) All full-term babies without risk factors born with Neonatal Jaundice 1 day 14 days Both Lack of parental consent The presence of major risk factors in the baby, including Cardiovascular, Pulmonary, Renal defects, etc. P59 Neonatal jaundice from other and unspecified causes Treatment - Drugs Placebo Intervention group: Receiving oral zinc sulfate syrup 1 cc/kg, each cc containing 1 mg of zinc while performing phototherapy, which is checked for 48 hours. Control group: Receiving a placebo of sucrose syrup with a concentration of 1cc/kg while performing phototherapy Total Bilirubin. Timepoint: Measurement of serum total bilirubin level at the beginning of the study (before the start of the intervention), 2 and 14 days after the start of oral zinc sulfate intake. Method of measurement: Blood examination. Zinc Sulfate level in serum. Timepoint: Immediately before and after phototherapy depending on the duration of phototherapy. Method of measurement: Blood examination. The duration of receiving phototherapy. Timepoint: Up to 14 days after the study. Method of measurement: Medical record. The length of hospitalization. Timepoint: Up to 14 days after the study. Method of measurement: Medical record. Tehran University of Medical Sciences Approved 2024-01-21 Tehran University of Medical Science Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)