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IRCT20201212049686N1 IRCT 2021-01-18 Tehran University of Medical Sciences Renal complications of Amikacin in patients with neonatal sepsis Study of the difference of renal complications in single and double daily dose of Amikacin in patients with neonatal sepsis in Imam Khomeini Hospital in Tehran: A double blind clinical trial 2019-06-05 anticipated 90 Complete https://irct.ir/trial/52966 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were randomly divided into two groups using block randomization. The number of samples assigned to each of the study groups and the size of the blocks were equal. Random allocation concealment was performed using Excel random number table and from the beginning of sampling, neonates with sepsis were coded according to the date of admission and were placed in each of the two groups according to random numbers, Blinding description: The patient, who was a newborn, did not know which group he was in, and the clinical caregiver and the researcher were blinded to the dose of the drug and the assignment of each patient to each group. The data analyzer and outcome assessor were also unaware of patient grouping. 3 neonatal Sepsis. Intervention 1: Intervention group: the first group received 15 mg/kg Amikacin once daily. Intravenous administration of amikacin made by Caspian Iran Company was performed for 7 days. Intervention 2: Intervention group: group received 10 mg/kg of Amikacin twice daily. Intravenous administration of amikacin made by Caspian Iran Company was performed for 7 days. Yes - There is a plan to make this available What will be shared: The data obtained from the study process recorded in the questionnaires and SPSS software will be provided to the journal if necessary for the submission of the article or at the request of the journal reviewer. When: From the time of article submission until any time after which data needs to be provided. To whom: If the journal is required to provide data in a supplementary file, all persons can access the data, and if the journal has requested the data, the reviewers and the journal editorial team can access it. Conditions: The data can be used to review the journal's referees upon request, and if requested as a supplemental file by the journal, all researchers can use the data to study or use in their future studies. Where to obtain: Dr. Mojtaba Fazel and Dr. Seyed Alireza Adel Barkhordar Imam Khomeini Hospital, Tehran - Children and NICU Ward E-mail: mojtabafazel@yahoo.com How to obtain: The requesting person gives an email to the given address explaining the reason for requesting access to the data and how to use the data. A letter of commitment form stating that the data will not be misused and violated copyright law will be signed by the applicant. After reviewing the request and consulting with the project partners, if the request is approved, data will be provided within 2-3 weeks. Comments:
public Mojtaba Fazel
Gharib St.
Tehran Iran (Islamic Republic of) 1419733134 +98 21 6119 2240 mojtabafazel@yahoo.com Tehran University of Medical Sciences scientific Mojtaba Fazel
Gharib St.
Tehran Iran (Islamic Republic of) 1419733134 +98 21 6119 2240 mojtabafazel@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) patients with neonatal sepsis Parental consent to participate in the study 3 days 1 month Both incomplete treatment parental dissatisfaction with continuing treatment evidence of asphyxia renal abnormalities at birth D50-D89 Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism Treatment - Drugs Treatment - Drugs Intervention group: the first group received 15 mg/kg Amikacin once daily. Intravenous administration of amikacin made by Caspian Iran Company was performed for 7 days. Intervention group: group received 10 mg/kg of Amikacin twice daily. Intravenous administration of amikacin made by Caspian Iran Company was performed for 7 days. GFR above 30%. Timepoint: Before and after seven days of treatment. Method of measurement: First, serum creatinine level was measured and GFR was calculated using the Schwartz formula: Creatinine clearance in millimeters per minute per 1/73 square meter of body surface =height in cm * K/ serum creatinine (in this formula: K in premature infants up to one year of age 0.33%, in infants Semester up to one year is 0.45%). Creatinine clearance. Timepoint: before one one week after Amikacin administration. Method of measurement: First, serum and urine creatinine were calculated and the creatinine clearance was calculated using the following formula: Urine creatinine * Urine volume / Serum creatinine. Tehran University of Medical Sciences Approved 2018-04-18 Ethics committee of Tehran University of Medical Sciences Gharib St., Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)