Validation of STARZ Score for Early Neonatal AKI (NCT07202858) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Validation of STARZ Score for Early Neonatal AKI
140 participantsStarted 2025-10-01
Plain-language 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."
Who can participate
Age range
0 Hours – 28 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Predictive accuracy of STARZ score for early neonatal AKI
Timeframe: Within the first 7 days of NICU admission