Validation of STARZ Score for Early Neonatal AKI

NCT07202858 | Not Yet Recruiting

• 1 other identifier: STARZ-AKI-NEO-Assiut
• Study Type: observational
• Target: 140
• Locations: 0 countries
• Sites: N/A

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."

Conditions

Acute Kidney Injury; Kidney Diseases; Newborn

Keywords

Neonatal Acute Kidney Injury; STARZ Score; NICU

Outcome Measures

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

  Within the first 7 days of NICU admission

Secondary Outcomes (1)

• Comparison of STARZ score with conventional AKI markers

  Within the first 7 days of NICU admission

Eligibility Criteria

• Age: 0 Hours - 28 Days
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (2)

• 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.

  PMID: 36189502 BACKGROUND

• 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.

  PMID: 38725209 BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury; Kidney Diseases

Condition Hierarchy (Ancestors)

Renal Insufficiency; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Menna Allah Talaat Mahmoud

CONTACT

+201019177153; Mennatalaat2018@gmail.con

Asmaa Ahmed Mahmoud

CONTACT

+201007041245

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Validation of the STARZ score in early prediction of neonatal acute kidney injury in Assuit university children hospital

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: October 2, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share