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IRCT20100102002954N22 IRCT 2020-11-21 Shahroud University of Medical Sciences Comparison of the effect of ampicillin and cefotaxime with ampicillin and amikacin in the treatment of neonatal sepsis Comparative study of the effect of ampicillin and cefotaxime antibiotics with ampicillin and amikacin in the treatment of early neonatal sepsis 2020-11-20 anticipated 94 Complete https://irct.ir/trial/51908 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be allocated into intervention and control groups according to random allocation table that illustrated by a statistician. Randomization will be done using permuted block randomization method (Block size of 4) using blocked random allocation syntax in SPSS software. Sample size will be 94 and number of blocks will be 24. Allocation concealment will be done using closed opaque envelope. 2-3 Early neonatal sepsis. Intervention 1: Intervention group: After initial and routine procedures including NICU admission, serum therapy and oxygen therapy, and stabilization of vital signs, ampicillin 50 mg / kg with cefotaxime 50 mg / kg will be given intravenously every 12 hours. Intervention 2: Control group: In the control group, as in the intervention group, while performing initial and routine procedures including hospitalization in the NICU, serum therapy and oxygen therapy and stabilization of vital signs, ampicillin 50 mg / kg with amikacin 7.5 mg / kg will be administered intravenously every 12 hours. 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 After the completion of the project and the determination of the results, a decision will be made by summarizing the opinions of all colleagues in this regard.
public Dr. Mahya Esmaili
Bahar Hospital, End 22 Bahman street, Shahroud, Iran.
Shahroud Iran (Islamic Republic of) 3616633525 +98 23 3224 5376 mahya.me.esmaili@gmail.com Shahroud University of Medical Sciences scientific Dr. Mahboobeh Mohammadi
Bahar hospital., End 22 Bahman street., Shahroud., Iran
Shahroud Iran (Islamic Republic of) 3616622355 +98 23 3224 7653 m_m361kord@yahoo.com Shahroud University of Medical Sciences Iran (Islamic Republic of) Infants with early sepsis in the first 7 days of life; Existence of respiratory distress, hypoxia or symptoms of acute respiratory distress syndrome; Poor perfusion or urinary output less than 0.5 cc / kg / hr; Metabolic acidosis with pH <7.2; Cardiovascular instability with a heart rate of less than 160 beats per minute; Decreased infant reflexes; Severe cyanosis; Frequent or prolonged seizures; Increase in body temperature to more than 38.5 or less than 36 ° C axillary; Apnea; Severe abdominal distension; And informed consent of parents to participate in the research. 1 day 7 days Both Infants with major congenital anomalies; Severe prematurity and less than 28 weeks; Very low birth weight (less than 1500 g); Congenital heart disease; Severe asphyxia (Apgar 5 minutes less than 5); A41 Other sepsis Treatment - Drugs Treatment - Drugs Intervention group: After initial and routine procedures including NICU admission, serum therapy and oxygen therapy, and stabilization of vital signs, ampicillin 50 mg / kg with cefotaxime 50 mg / kg will be given intravenously every 12 hours. Control group: In the control group, as in the intervention group, while performing initial and routine procedures including hospitalization in the NICU, serum therapy and oxygen therapy and stabilization of vital signs, ampicillin 50 mg / kg with amikacin 7.5 mg / kg will be administered intravenously every 12 hours. 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 of hospitalization. Timepoint: At the end of the study. Method of measurement: The time between the time / date of hospitalization and the time / date of discharge from the hospital, expressed in hours. Mortality rate. Timepoint: At the end of the study. Method of measurement: Mortality rate refers to the number of deaths among these infants, expressed as a percentage. Vice chancellor for research; Shahroud University medical and Sciences Approved 2020-10-25 Ethics committee of Shahroud University of Medical Sciences Shahroud University of Medical Sciences; 7 Tir squer, Shahroud Shahroud Semnan Iran (Islamic Republic of)