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临床试验/NCT07202858
NCT07202858尚未招募不适用

Validation of the STARZ Score for Early Prediction of Neonatal Acute Kidney Injury in Assuit University Children Hospital

Assiut University0 个研究点目标入组 140 人开始时间: 2025年10月1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
140
主要终点
Predictive accuracy of STARZ score for early neonatal AKI

研究概览

简要总结

Neonatal acute kidney injury (AKI) is a common complication in the NICU, associated with high morbidity and mortality. Prematurity, low birthweight, sepsis, asphyxia, congenital heart disease, and nephrotoxic drugs are major risk factors. Early diagnosis is challenging as serum creatinine lacks sensitivity. The STARZ score, a composite clinical-laboratory tool, has shown high accuracy for predicting early neonatal AKI. This study aims to validate the STARZ score in neonates admitted to Assiut University Children's Hospital for early identification of AKI and improved clinical outcomes."

详细描述

Neonatal acute kidney injury (AKI) is a frequent and serious complication in the neonatal intensive care unit (NICU), with incidence rates ranging from 6% to 24% and reaching up to 70% in high-risk populations depending on diagnostic criteria. Prematurity, low birthweight, sepsis, perinatal asphyxia, congenital heart disease, respiratory distress, shock, and exposure to nephrotoxic medications are established risk factors. Neonatal AKI is associated with increased mortality, prolonged hospitalization, and long-term renal complications, including chronic kidney disease.

Traditional diagnostic tools, such as serum creatinine, are limited by delayed changes and poor sensitivity in neonates. Risk stratification models offer an opportunity for earlier detection and proactive intervention. The STARZ score is a composite risk assessment tool incorporating clinical and laboratory parameters, and has demonstrated high predictive accuracy in previous studies, with sensitivity above 85% and specificity around 90% for early neonatal AKI.

This prospective study at Assiut University Children's Hospital aims to validate the STARZ score for predicting neonatal AKI within the first 7 days of NICU admission. The study will assess its predictive performance compared with conventional criteria, evaluate its role in risk stratification and guiding timely interventions, and examine the potential benefits in terms of cost-effectiveness and healthcare resource utilization.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
0 Hours 至 28 Days(Child)
性别
All
接受健康志愿者
否

入选标准

  • 未提供

排除标准

  • •Neonates with known congenital renal anomalies diagnosed antenatally or postnatally.
  • •Neonates with chromosomal abnormalities or genetic syndromes affecting renal function.
  • •Neonates discharged, transferred, or deceased within 24 hours of admission.
  • •Neonates with incomplete medical records or missing key laboratory data

结局指标

主要结局

Predictive accuracy of STARZ score for early neonatal AKI

时间窗: Within the first 7 days of NICU admission

Validation of the STARZ risk stratification score for identifying neonates at risk of AKI within the first 7 days of NICU admission

次要结局

  • Comparison of STARZ score with conventional AKI markers(Within the first 7 days of NICU admission)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Menna Allah Talaat Mahmoud

Validation of the STARZ score in early prediction of neonatal acute kidney injury in Assuit university children hospital

Assiut University

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