Follow-up of AKI in Neonates During Childhood Years

Study Overview
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Brief Summary
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The purpose of this study is to learn more about how to identify signs of early chronic kidney diseases in children who were born prematurely with low birth weight (less than 3 ½ pounds). Researchers plan to compare the kidney function in children who experienced acute kidney injury (AKI) in the Neonatal Intensive Care Unit (NICU) with those who did not experience it. Evidence from several studies and our experience at UVA show that older children who experienced AKI while in the Pediatric Intensive Care Unit (PICU) have increased risk of developing early chronic kidney disease, and they also show early changes in the urine and blood that is consistent with early chronic kidney disease. In this study, the investigators hope to determine if any of these changes can be detected in early childhood, and if so, at what age we can start detecting these changes.

Official Title
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Long Term Follow-up of Acute Kidney Injury in Very Low Birth Weight Infants

Conditions
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Neonatal Acute Kidney Injury, Childhood Chronic Kidney Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Premature birth for Premature groups UVA NICU admission prior to 2 days of life Birth weight less than 1500 grams for premature groups Premature AKI Study group: Acute Kidney Injury as defined by KDIGO modified criteria during NICU stay at UVA Premature no AKI Control group: No AKI during NICU stay Term no AKI Control group: No AKI and born at term Parental or legal guardian consent obtained Exclusion Criteria: - Patients with Congenital Anomalies of the Kidney and Urinary Tract

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Premature Acute Kidney Injury in NICU<br>This group of babies born less than 1500 grams will have experienced acute kidney injury based on the modified KDIGO guidelines for acute kidney injury. | |
| Premature No Acute Kidney Injury in NICU<br>This group of babies born less than 1500 grams will have not experienced acute kidney injury in the NICU. | |
| Term No Acute Kidney Injury<br>This group of babies born at term will have not experienced any acute kidney injury. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite Abnormality | Either eGFR > 90, urine protein/creatinine > 0.2, or BP > 95th percentile for age and height | Age 2-7 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth | Evaluation of height, weight and BMI | Age 2-6 years | 
| Kidney Size | Evaluation of kidney size | Age 2-6 years | 
| Urinary Biomarkers | Evaluation of urine for biomarkers which can be used to detect early chronic kidney disease | Age 2-6 years |