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IRCT20231120060123N1 IRCT 2023-11-21 Mashhad University of Medical Sciences effects of Silymarin in the Prevention of hyperbilirubinemia Investigating the effects of Silymarin in the Prevention of hyperbilirubinemia: a randomized, double-blind, placebo-controlled, clinical trial 2023-12-22 anticipated 120 Complete https://irct.ir/trial/73851 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization method: simple Randomization tool: closed envelope Allocation Concealment: sealed envelopes containing random and equal sequence contents from two intervention and control groups, Blinding description: This is a double-blind study in which the researcher and the patient do not know about the type of drug. Drugs and placebos are exactly the same in shape, color, smell, and glass, and are codenamed A and B. After collecting the data, the codes are opened and the drug and placebo are identified. 3 Neonatal jaundice, unspecified. Intervention group: In the intervention group, newborns receive oral silymarin drops from the first day of birth at a dose of 4 mg per kilogram of body weight every 12 hours. The silymarin, with a concentration of 4 mg per cc, is prepared by the Medicinal Plants Research Center of Mashhad University of Medical Sciences. The transcutaneous bilirubin level will be measured 24, 48, and 72 hours after the start of treatment.. Yes - There is a plan to make this available What will be shared: All data can be shared after patients are made unidentifiable. When: Data can be accessible 6 months after results are published. To whom: Data will be available for researchers in universities and other scientific institute Conditions: After publication as an article, it can be used by the public and researchers of medical universities Where to obtain: Data can be accessible through an email to the corresponding author. How to obtain: After sending a request email to the corresponding author, data will be sent in 1 month. Comments:
public Hamidreza Goldouzi
Neonatal intensive care unit, Ghaem hospital, Dr. Shariati Square, Ahmadabad St.
Mashhad Iran (Islamic Republic of) 9176699199 +98 51 3801 2502 GoldouziHR4011@mums.ac.ir Mashhad University of Medical Sciences scientific Gholam Ali Maamouri
Neonatal intensive care unit, Ghaem hospital, Dr. Shariati Square, Ahmadabad St.
Mashhad Iran (Islamic Republic of) 9176699199 +98 51 3801 2502 maamourigh@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Full-term newborns who are negative for the Coombs test at birth. Healthy full-term newborns who do not require phototherapy. Newborns whose bilirubin levels are not in the range requiring blood exchange. Newborns with no history of the mother taking any kind of medication during pregnancy. 2 days 10 days Both Newborns with RH incompatibility who are positive for the Coombs test. Newborns with an increase in bilirubin to the level requiring blood exchange. Newborns requiring phototherapy on the first day of birth. Deterioration in the newborn's condition during hospitalizationwith dehydration, sepsis, pneumonia, anemia, severe weight loss, hypoglycemia, renal failure, or heart failure. Newborns with a history of the mother taking any kind of medication during pregnancy or mothers who have received phenobarbital. Newborns who experience severe drug reactions following the use of silymarin. Parents' refusal to continue treatment. P59.9 Neonatal jaundice, unspecified Prevention Intervention group: In the intervention group, newborns receive oral silymarin drops from the first day of birth at a dose of 4 mg per kilogram of body weight every 12 hours. The silymarin, with a concentration of 4 mg per cc, is prepared by the Medicinal Plants Research Center of Mashhad University of Medical Sciences. The transcutaneous bilirubin level will be measured 24, 48, and 72 hours after the start of treatment. Transcutaneous bilirubin level. Timepoint: 24,48 and 72 hours after birth. Method of measurement: Bilichek device. Mashhad University of Medical Sciences Approved 2023-09-19 Ethics committee of Mashhad University of Medical Sciences Azadi Square, east door of the university campus Mashhad Razavi Khorasan Iran (Islamic Republic of)