Acute Kidney Injury, Kidney Diseases, Newborn
Conditions
Keywords
Neonatal Acute Kidney Injury, STARZ Score, NICU
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Assiut University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Hours to 28 Days
Inclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Predictive accuracy of STARZ score for early neonatal AKI | 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
| Measure | Time frame | Description |
|---|---|---|
| Comparison of STARZ score with conventional AKI markers | Within the first 7 days of NICU admission | Evaluate sensitivity, specificity, and predictive values of STARZ score versus serum creatinine and urine output |
Contacts
Primary ContactMenna Allah Talaat Mahmoud
Backup ContactAsmaa Ahmed Mahmoud
Outcome results
None listed