Follow-up of AKI in Neonates During Childhood Years

• Conditions: Childhood Chronic Kidney Disease; Neonatal Acute Kidney Injury

• Registration Number: NCT02306642
• Lead Sponsor: Matthew Harer, MD

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-01
• Study First Submitted QC: 2014-12-02
• Study First Posted: 2014-12-03
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-10
• Last Update Posted: 2016-05-12
• Primary Completion: 2017-03
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite Abnormality	Age 2-7 years	Either eGFR \> 90, urine protein/creatinine \> 0.2, or BP \> 95th percentile for age and height

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States