Role of Zinc in Neonatal sepsis: A double blinded, randomized, placebo controlled trial

il0 个研究点目标入组 614 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Inborn and Outborn neonates >32 weeks (By Ballard scoring) with Probable Neonatal Sepsis* will be included in this study.
•*According to the guidelines formulated by the National Neonatology Forum of India based on the duly approved tenth revision of the International Classification of Diseases (ICD) by the WHO, in an infant having a clinical picture suggestive of sepsis, the presence of any one of the following criteria is enough to suspect the diagnosis of Bacterial Infection:
•1)Existence of any of the predisposing factors like Premature Rupture of membranes (PROM), foul smelling liquor, Amnionitis or Funisitis, Gastric Polymorphs of more than 5/HPF.
•2)Positive sepsis screen i.e. presence of atleast two of the following five parameters, namely, total leucocyte count < 5000/mm3, Low absolute neutrophil count (as per standard charts), Bands to Total neutrophil ratio (IT Ratio) of >0.2, C-Reactive Protein > 1mg/dl, Micro ESR > 15mm in first hour on any day of life/ age in days+3

•The following categories of babies will be excluded from the trial:Preterm neonates < 32 weeks
•Neonates with Congenital Malformations
•Neonates with NEC

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