Validation of STARZ Score for Early Neonatal AKI
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-28
SponsorAssiut University
About this trial
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."
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
Neonates admitted to the neonatal intensive care unit (NICU) at Assiut University Children's Hospital within the first 24 hours of life. Both preterm and term neonates will be included. Participants will be evaluated for the risk of developing acute kidney injury (AKI) using the STARZ score during the first 7 days of admission.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Predictive accuracy of STARZ score for early neonatal AKI
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 admissionSecondary outcomes
1
Comparison of STARZ score with conventional AKI markers
Evaluate sensitivity, specificity, and predictive values of STARZ score versus serum creatinine and urine output
Time frame
Within the first 7 days of NICU admissionLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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