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NCT Number: NCT07202858

Validation of STARZ Score for Early Neonatal AKI

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."

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Key information

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

  • Neonates admitted to the NICU within 48 hours of birth.
  • Gestational age ≥ 28weeks.
  • Birth weight ≥ 1000grams.
  • Neonates with clinical indications necessitating laboratory investigations relevant to kidney function monitoring as part of standard care.
  • Parental or guardian consent obtained for study participation.

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Predictive accuracy of STARZ score for early neonatal AKI

    Time frame: 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

Secondary outcomes

  1. Comparison of STARZ score with conventional AKI markers

    Time frame: Within the first 7 days of NICU admission

    Evaluate sensitivity, specificity, and predictive values of STARZ score versus serum creatinine and urine output

Study contacts

Contact information is provided by the study sponsor or research team.

Asmaa Ahmed Mahmoud

CONTACT

+201007041245

Menna Allah Talaat Mahmoud

CONTACT

[email protected]

+201019177153

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 2, 2025
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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