跳至主要内容
临床试验/CTRI/2025/03/082587
CTRI/2025/03/082587尚未招募不适用

Correlation of neutrophil to leukocyte ratio(NLR) and mean platelet volume (MPV) with sepsis screen and blood culture in neonatal sepsis - A prospective observational study

Dr Mouna S1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年4月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
To correlate the efficacy of NLR and MPV with sepsis screen and blood culture in predicting neonatal sepsis

研究概览

简要总结

Neonates who fulfil the inclusion criteria will be included in the study. Demographic data will be entered in pre designed proforma. At the time of admission gestational age will be calculated using extended new ballard scoring, Blood culture and sensitivity will be sent at admission and/or before starting antibiotics. sepsis screen will be sent after 4 hour of life /admission which ever is later.

Peripheral smear will be used to calculate neutrophil to leucocyte ratio and I:T ratio. All babies will be managed as per standard protocols. Repeat sepsis screen and blood culture will be sent if clinical condition worsens or warrants upgrade of antibiotics. This will be documented as separate variable, will not be considered for sampling. This will be analysed separately. Outcome of all cases, deaths/discharges and number of days of hospital stay will be recorded. All data will be recorded in Microsoft excel sheet.

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Day(s) 至 28.00 Day(s)(—)
性别
All

入选标准

  • Both inborn and outborn neonates who are admitted to BGSGIMS NICU ,with either of, 1.more than 34 weeks of gestation with antenatal 2.risk factors for sepsis 3.PROM more than 18hrs 4.Prepartum fever 5.Chorioamnionitis 6.With clinical features of sepsis : 7.Hypothermia or fever with temperature instability Lethargy, refusal of feeds Hypotonia Bradycardia or tachycardia Respiratory distress Hypotension or shock.

排除标准

  • Neonates with congenital anomaly.
  • Neonate with proven blood culture sepsis.
  • Neonates started on prior antibiotics.
  • Neonates with birth asphyxia.
  • Refusal to give consent.

结局指标

主要结局

To correlate the efficacy of NLR and MPV with sepsis screen and blood culture in predicting neonatal sepsis

时间窗: Baseline

次要结局

  • To determine the predictability of neonatal sepsis by NLR and MPV(at the end of study)

研究者

发起方
Dr Mouna S
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Mouna S

BGS Global Institute of Medical Sciences

研究点 (1)

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