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临床试验/CTRI/2018/01/011453
CTRI/2018/01/011453招募中未知

Duration of Antibiotic Therapy in Neonatal Gram Negative Bacterial Sepsis -10 days vs. 14 days: a Randomized Controlled Trial

ONE0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
招募中
发起方
ONE

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • Neonates with gestational with birth weight > 1500 g, who satisfy all the following criteria will be enrolled:
  • i.Clinical signs of sepsis as per NEOKISS criteria present before antibiotic therapy (Appendix I) in addition to other signs
  • ii.Blood culture showing growth of a pathogenic GNB
  • iii.Repeat blood culture after 7 days of sensitive antibiotic therapy should be sterile
  • iv.Infant should be in remission defined as being on full feeds, not on mechanical ventilation (except high flow nasal cannulae) or on inotropes.

排除标准

  • The following patients will be excluded:
  • 1.Infants born with major congenital malformations such as diaphragmatic hermia, abdominal wall defects, neural tube defects, esophageal atresia with/without fistula etc.
  • 2.Severe birth asphyxia (defined as APGAR score <3 at 5 minutes).
  • 3.Infants being planned to be treated for neonatal meningitis as per attending neonatologist [ ].
  • 4.Those undergoing or underwent major surgeries.
  • 5.Infants with clinically evident bone (osteomyelitis) / joint (arthritis) [1].
  • 6.Infants whose blood cultures were interpreted as â??contaminant or possible contaminantâ??.
  • 7.Refusal of consent or unlikely to follow up for 28 days.

研究者

发起方
ONE

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