Validation of STARZ Score for Early Neonatal AKI

NCT ID: NCT07202858

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 140 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2027-11-30

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.

Conditions

Acute Kidney Injury; Kidney Diseases; Newborn

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 0 Hours
• Maximum Eligible Age: 28 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Menna Allah Talaat Mahmoud

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Menna Allah Talaat Mahmoud

Role: CONTACT

Mennatalaat2018@gmail.con

+201019177153

Asmaa Ahmed Mahmoud

Role: CONTACT

+201007041245

References

Dhooria GS, Nautiyal A, Wazir S, Agrawal G, Tiwana A, Bajaj N, Gupta NP, Mirgunde S, Sahoo J, Balachandran B, Afzal K, Shrivastava A, Bagla J, Krishnegowda S, Konapur A, Soni K, McCulloch M, Bunchman T, Sethi SK, Raina R. Validation of the STARZ neonatal acute kidney injury risk stratification score in an independent prospective cohort. J Neonatal Perinatal Med. 2022;15(4):777-785. doi: 10.3233/NPM-221044.

Reference Type: BACKGROUND

PMID: 36189502 (View on PubMed)

Gupta S, Gaur BK, Jain R, Singh RR. Incidence, Risk Factors, and Outcomes of Acute Kidney Injury in Preterm Neonates Hospitalized in the Neonatology Unit, North India: A Single-center Experience. Saudi J Kidney Dis Transpl. 2023 Nov 1;34(6):592-601. doi: 10.4103/sjkdt.sjkdt_264_23. Epub 2024 May 9.

Reference Type: BACKGROUND

PMID: 38725209 (View on PubMed)

Other Identifiers

STARZ-AKI-NEO-Assiut

Identifier Type: -

Identifier Source: org_study_id