Меню
Набор скоро начнётся NCT07202858

Validation of STARZ Score for Early Neonatal AKI

— Наблюдательное Acute Kidney Injury Kidney Diseases Newborn

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Acute Kidney Injury, Kidney Diseases, Newborn. Базовые параметры: 0 Hours — 28 Days · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Validation of the STARZ Score for Early Prediction of Neonatal Acute Kidney Injury in Assuit University Children Hospital

Обзор

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."

Подробное описание

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.

Первичные конечные точки

  • Predictive accuracy of STARZ score for early neonatal AKI [Срок оценки: Within the first 7 days of NICU admission]
Вторичные конечные точки (1)
  • Comparison of STARZ score with conventional AKI markers [Срок оценки: Within the first 7 days of NICU admission]

Критерии участия

  • 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.

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • 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/NP PMID 36189502
  • 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

Идентификаторы

NCT: NCT07202858 · STARZ-AKI-NEO-Assiut

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗