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Clinical Trials/NCT02306642
NCT02306642
Unknown
Not Applicable

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

Matthew Harer, MD1 site in 1 country80 target enrollmentDecember 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neonatal Acute Kidney Injury
Sponsor
Matthew Harer, MD
Enrollment
80
Locations
1
Primary Endpoint
Composite Abnormality
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2014
End Date
June 2017
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Matthew Harer, MD
Responsible Party
Sponsor Investigator
Principal Investigator

Matthew Harer, MD

Neonatal-Perinatal Medicine Fellow, MD

University of Virginia

Eligibility Criteria

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

Outcomes

Primary Outcomes

Composite Abnormality

Time Frame: Age 2-7 years

Either eGFR \> 90, urine protein/creatinine \> 0.2, or BP \> 95th percentile for age and height

Secondary Outcomes

  • Growth(Age 2-6 years)
  • Kidney Size(Age 2-6 years)
  • Urinary Biomarkers(Age 2-6 years)

Study Sites (1)

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