Follow-up of AKI in Neonates During Childhood Years

Childhood Chronic Kidney Disease Clinical Trial

— FANCY  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02306642
• Other study ID #: 17540
• Status: Recruiting
• Phase: N/A
• First received: December 1, 2014
• Last updated: January 19, 2016
• Start date: December 2014
• Est. completion date: June 2016

Study information

• Verified date: January 2016
• Source: University of Virginia
• Contact: Matthew W Harer, MD
• Phone: 434-243-9470
• Email: mwh9g[@]virginia.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 7 Years

Eligibility

Inclusion Criteria:

• Premature birth for Premature groups

• UVA NICU admission prior to 7 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

• SGA patients

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Acute Kidney Injury
• Childhood Chronic Kidney Disease
• Kidney Diseases
• Neonatal Acute Kidney Injury
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Matthew Harer, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimated GFR	Estimated GFR from serum creatinine or cystatin C	Age 2-6 years	No
Primary	Proteinuria	Evidence of elevated amounts of protein in urine	Age 2-6 years	No
Secondary	Blood Pressure	Evidence of increased systolic or diastolic blood pressure	Age 2-6 years	No
Secondary	Growth	Evaluation of height, weight and BMI	Age 2-6 years	No
Secondary	Kidney Size	Evaluation of kidney size	Age 2-6 years	No
Secondary	Urinary Biomarkers	Evaluation of urine for biomarkers which can be used to detect early chronic kidney disease	Age 2-6 years	No