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临床试验/CTRI/2023/05/052978
CTRI/2023/05/052978尚未招募不适用

VALIDATION OF THE STARZ NEONATAL ACUTE KIDNEY INJURY RISK STRATIFICATION SCORE (PROSPECTIVE COHORT STUDY)

未提供1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年5月31日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1
主要终点
Evaluation of the validity of STARZ (Sethi, Tiberwal, Agrawal, Raina, WaZir) score for the prediction of acute kidney injury in all neonates after 12 hrs of hospital admission.

研究概览

简要总结

Early detection of AKI among neonates is important to prevent short & long term effects as well as mortality. Unfortunately no agreement has been reached on its best screening method, especially as some of the suggested markers were less accurate or impractical or not 24/7 readily unavailable in less developed centres[5].

A" Neonatal AKI Risk Prediction Scoring" was created - "STARZ" (Sethi, Tiberwal, Agrawal, Raina, Wazir) score. This scoring model is used to predict the risk of AKI in neonates any time within 7 days post admission in hospital. This score has 10 independent variables(3Continuous and, 7categorical). Some of these variables are available at the time of admission while others are reported at 12 hr post-admission. Therefore, the score can be calculated anytime post 12 hr of admission.

For scoring each of the significant variable is assigned a score with zero indicating the reference group. The scale ranges from 0 to 100, and a cut-off score is >31.5, where a higher score is proportional to the probability of AKI occuring within 7 days.

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

  • •All Neonates (<28 days)admitted to emergency ward and NICU with established IV access to receive an IV fluid for > 48 hours to deliver nutrition and/or hydration.

排除标准

  • •1.The neonate died within 48 hours upon admission. 2.The presence of any lethal chromosomal anomaly (like trisomy 13,18,anencephaly).
  • •3.The neonate who required congenital heart surgery within the first 7 days of being delivered due to potential concurrent congenital kidney dysfunction. 4.The neonate with previously diagnosed congenital kidney anomalies.Â.

结局指标

主要结局

Evaluation of the validity of STARZ (Sethi, Tiberwal, Agrawal, Raina, WaZir) score for the prediction of acute kidney injury in all neonates after 12 hrs of hospital admission.

时间窗: 1 year

次要结局

  • Describe the outcome of the included cohort.(Estimate the frequency and duration of usage of nephrotoxic drugs in newborns.)

研究者

发起方
未提供

研究点 (1)

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