跳至主要内容
临床试验/CTRI/2021/12/038553
CTRI/2021/12/038553尚未招募未知

â??Evaluation of efficacy of Presepsin as a sepsis biomarker in Neonatal Sepsis-A pilot studyâ??

AIIMS Raipur0 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
尚未招募
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

入选标准

  • ï?ª All Neonates admitted in Neonatal unit with clinical suspicion of sepsis for
  • whom either workup for sepsis or blood culture will be sent before initiation
  • of antibiotics.
  • ï?ª Diagnosis of sepsis would be based on presence of clinical findings (one or
  • more than one clinical finding) which would include the following 1. Respiratory compromise: respiratory rate >60 breaths per minute, or
  • cessation of respiration for >=20 seconds, occurring at a rate of >=2
  • times per hour, or pulse oxymeter readings of <=90%
  • 2. Cardiovascular compromise: heart rate <100 beats per minute or
  • more than 180/min with other physiological causes ruled out,
  • pallor,or hypotension.
  • 3. Metabolic changes: hypothermia (rectal temperature <36°C),a body
  • temperature of >38ï?°C, feeding intolerance (increased gastric
  • residuals >50% of milk volume in >=2 feedings within 24 hours),
  • glucose instability (blood glucose level <45 or >125 mg/dL), or
  • metabolic acidosis (pH < 7.25); or
  • 4. Neurologic changes: lethargy or decreased activity
  • ï?ª These clinical criteria is not all inclusive. All other condition leading to
  • clinical suspicion of sepsis will be included.

排除标准

  • Neonates who had recently undergone surgical interventions.
  • ï?· Patients who had confirmed intrauterine infection (toxoplasmosis, rubella,
  • cytomegalovirus, syphilis, and herpes).
  • ï?· Babies having major malformations and inborn error of metabolism (IEM).
  • ï?· Patients for whom consent cannot be taken from the parents.

研究者

发起方
AIIMS Raipur

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