Biorepository to Support Research in Kidney Diseases
NCT04343417
Acute Interstitial Nephritis, Acute Kidney Injury
New Haven, Connecticut, United States
View Trial DetailsNCT Number: NCT07202858
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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All sexes
Observational
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.
Only the study team can determine whether someone qualifies for participation.
Exclusion criteria
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
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
Contact information is provided by the study sponsor or research team.
Asmaa Ahmed Mahmoud
CONTACT
Menna Allah Talaat Mahmoud
CONTACT
Assiut University
Other
Validation of the STARZ Score for Early Prediction of Neonatal Acute Kidney Injury in Assuit University Children Hospital
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