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IRCT201504289568N13 IRCT 2015-06-02 Shahed university Examination of the Effect of Antibiotics on Inflammatory Factors in Neonates Examination of proinflammatory and inflammatory cytokines in full-term neonates suspected of sepsis prior to and 12 hours after antibiotic therapy (pilot study) 2015-05-22 anticipated 40 Complete https://irct.ir/trial/10138 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Prevention. N/A Bacterial sepsis of newborn. Antibiotic therapy with ampicilin+amikacin or rarely vancomycin+meropenem.
public Golnaz Rezaeizadeh
Vaiasr hospital,Imam Khomeini Hospital complexex, Keshavarz blv, Tehran, Iran
Tehran Iran (Islamic Republic of) +98 21 6659 1316 golnaz_rezaei80@yahoo.com Maternal Fetal Neonatal Research Center,Tehran University of Medical Sciences scientific golnaz rezaeizadeh
Vaiasr hospital,Imam Khomeini Hospital complexex, Keshavarz blv, Tehran, Iran
Tehran Iran (Islamic Republic of) +98 21 6659 1316 golnaz_rezaei80@yahoo.com Maternal Fetal Neonatal Research Center,Tehran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: All healthy full-term babies, having healthy mothers and normal Apgar scores, suspected of sepsis and candidates for antibiotic treatment in the NICU of Vali-e Asr Hospital. Exclusion criteria: Infants with positive blood cultures, infants with positive cerebrospinal fluid culture, infants being treated with corticosteroids, infants whose mothers were treated with corticosteroids or magnesium sulphate at least one week prior to delivery, infants whose mothers received antibiotics prior to delivery, cord acidosis and birth asphyxia, infants that are intravenously fed, and infants of ill mothers. no limit 28 days Both P36 Bacterial sepsis of newborn Treatment - Drugs Antibiotic therapy with ampicilin+amikacin or rarely vancomycin+meropenem IL-1β. Timepoint: just before and 12 hrs after intervention. Method of measurement: ELISA,pg/ml. IL-6. Timepoint: just before and 12 hrs after intervention. Method of measurement: ELISA,pg/ml. IL-8. Timepoint: just before and 12 hrs after intervention. Method of measurement: ELISA,pg/ml. TNF-α. Timepoint: just before and 12 hrs after intervention. Method of measurement: ELISA,pg/ml. Tehran University of Medical Sciences Shahed university Tehran University of Medical Sciences Approved 2015-04-28 Tehran University of Medical Sciences Ethics committee of Tehran University of Medical Sciences,6 th floor of Tehran University of Medical Tehran Iran (Islamic Republic of)