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IRCT20180404039187N7 IRCT 2020-06-22 Tabriz University of Medical Sciences evaluation effect of Pentoxifylline in sepsis. The study of efficacy of Pentoxifylline in late Sepsis in preterm neonate(Trial clinical randomized) 2020-04-20 anticipated 40 Complete https://irct.ir/trial/44503 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Arrangement of the randomization process: 1) Determining the volume of each block (quadruple blocks) 2) Preparing the list of the blocks and assigning a number to each of them AABB(1) ABAB(2) ABBA(3) BBAA(4) BABA(5) BAAB(6) 3) Choosing random numbers between 1 and 6 4) Defining the treatment assignment list For example: AABB(1)_BBAA(4)_ABAB(2)_BABA(5), Blinding description: The participants (patients) are all blind during the study. At the patient's level, blindness will be done as the patients do not know in which group (control or intervention group) they are in. only The researcher has been informed and prescribes to patients according to the randomized list. 3 neonatal late sepsis. Intervention 1: Intervention group: received Pentoxyfilin orally at a dose of 10 mg/kg every eight hours for 6 day with routin antibiotic treatment(Amikacin at a dose of 15-20 mg\kg-Vankomycin at a dose of 45-60 mg\kg\day divided every 6-8 hours). Intervention 2: Control group: received routin antibiotic for sepsis(Amikacin at a dose of 15-20 mg\kg-Vankomycin at a dose of 45-60 mg\kg\day divided every 6-8 hours with supportive oxygen therapy). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is I have no definituve decision.
public Tabriz University of Medical Sciences
Faculty of Pharmacy, Tabriz university of Medical Science, Golgasht Ave.,Azadi Ave.
Tabriz Iran (Islamic Republic of) 5166614766 0098 144933344198 Elnaz_shaseb_64@yahoo.com Tabriz University of Medical Sciences scientific Elnaz Shaseb
Faculty of Pharmacy, Tabriz university of Medical Science, Golgasht Ave.,Azadi Ave.
Tabriz Iran (Islamic Republic of) 5166614766 0098 144933344198 Elnaz_shaseb_64@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Preterm neonate with positive blood culture of sepsis clinical signs of sepsis: temprature instability respiratory disorders cardiovascular disorders gastrointestinal disorders preterm neonates with late onset sepsis(having sepsis 72 hours after birth) no limit 259 days Both neonate with cranial hemorrhage maternal infection renal disorders neonate with tolerance to xanthine products that cause anaphylactic reaction A41 Other sepsis Treatment - Drugs Treatment - Drugs Intervention group: received Pentoxyfilin orally at a dose of 10 mg/kg every eight hours for 6 day with routin antibiotic treatment(Amikacin at a dose of 15-20 mg\kg-Vankomycin at a dose of 45-60 mg\kg\day divided every 6-8 hours) Control group: received routin antibiotic for sepsis(Amikacin at a dose of 15-20 mg\kg-Vankomycin at a dose of 45-60 mg\kg\day divided every 6-8 hours with supportive oxygen therapy) Number of hospitalized days. Timepoint: During the study. Method of measurement: Count the days of hospitalization. Duration of making CRP marker negative. Timepoint: At the beginning and during the study. Method of measurement: laboratory tests. Need for intubation and mechanical ventilarion. Timepoint: During the study. Method of measurement: Checking patient records. Metabolic acidosis. Timepoint: During the study. Method of measurement: Laboratory test(ABG). Duration needed for oxygene therapy. Timepoint: During the study. Method of measurement: Counting days under oxygen therapy. Tabriz University of Medical Sciences Approved 2019-12-25 Ethics Committee of Tabriz University of Medical Sciences Research & Technology Dept, Central Building No. 2, Third Floor, Tabriz University of Medical Sciences, Golghast St, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)