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IRCT20231210060317N1 IRCT 2023-12-24 Shahid Beheshti University of Medical Sciences Melatonin Administration as an Adjuvant Therapy in Preterm Infants with Neonatal Jaundice Melatonin Administration as an Adjuvant Therapy in Preterm Infants with Neonatal Jaundice 2024-01-20 anticipated 60 Complete https://irct.ir/trial/74462 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: To randomize the study samples, we will use restricted randomization, specifically block randomization. All block sizes will be equal, using blocks of 4 (including 2 neonates in the control group and 2 in the melatonin group), Blinding description: In this study, after explaining the objectives of the research to the parents and obtaining written consent, the infants were randomly assigned to one of the two groups of case and control. Each patient is assigned a code, and parents are unaware of whether their child is in the control group or the case. In the same way, the researcher only had the task of allocating patients to two groups number one and two, and is not aware of the definition of groups one and two. After assigning the patient to one of the desired groups, the necessary intervention is carried out by a specialist in the neonatal department, and the results are evaluated and recorded by the evaluation, which has the task of collecting the results of the results based on the patient's code. 3 Neonatal jaundice. Intervention 1: Intervention group: Neonates in this group will receive 0.5 mg/kg/day oral melatonin drops in addition to phototherapy. Intervention 2: Control group: Neonates in this group will only receive phototherapy. Yes - There is a plan to make this available What will be shared: In this study, after completing the study, all potential data will be shared with other researchers through the Research Gate data-sharing system after de-identifying the patients. When: Access will start from the time the results are printed. To whom: The data will be publicly available to all interested parties through the link created on the researcher's Research Gate page. Conditions: The use of research data for future studies by referring to the main published article of the present research will be unimpeded. Where to obtain: The data will be transparently accessible through the link included in the final article. How to obtain: The data will be transparently accessible through the link included in the final article. Comments:
public Farzaneh Ahmadi Khatiri
Shariati Ave, Mofid Children's hospital, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1546815514 +98 21 2222 7033 Ahmadikhatiri@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Farzaneh Ahmadi Khatiri
Shariati Ave, Mofdi children's hospital, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1546815514 +98 21 2222 7033 Ahmadikhatiri@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Gestational age 32-37 weeks Serum bilirubin level below exchange transfusion threshold Indirect hyperbilirubinemia Postnatal age under 30 days 3 days 30 days Both Underlying diseases and congenital anomalies in the neonate Any signs of neonatal sepsis or other infections Signs and risk factors of hemolysis Acute or chronic respiratory diseases P59.0 Neonatal jaundice associated with preterm delivery Treatment - Drugs N/A Intervention group: Neonates in this group will receive 0.5 mg/kg/day oral melatonin drops in addition to phototherapy. Control group: Neonates in this group will only receive phototherapy. Serum bilirubin level (mg/dL). Timepoint: Serum bilirubin levels will be measured in both groups before the intervention (T0), on the first day (T1), and on the second day (T2) after the intervention. Method of measurement: Blood test. Shahid Beheshti University of Medical Sciences Approved 2023-09-30 Research Ethics Committee of Shahid Beheshti University of Medical Sciences Velenjak, Daneshjou Blvd, Shahid Beheshti University of medical sciences, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)