Recruiting

Observational Study

Sponsor:

Matthew Harer, MD

Code:

NCT02306642

Conditions

Neonatal Acute Kidney Injury

Childhood Chronic Kidney Disease

Eligibility Criteria

Sex: All

Age: 2 - 7

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Neonatal Acute Kidney Injury

Childhood Chronic Kidney Disease

Study ID

NCT02306642

Start date

Dec, 2014

Status verified date

May, 2016

Completion date

Jun, 2017

Anticipated

Primary completion date

Mar, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 7

Healthy Volunteers: Accepted

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

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

Premature Acute Kidney Injury in NICU

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

This group of babies born less than 1500 grams will have not experienced acute kidney injury in the NICU.

Term No Acute Kidney Injury

This group of babies born at term will have not experienced any acute kidney injury.

Primary outcome measure

  • Composite Abnormality [ Time Frame: Age 2-7 years ]

Central Contacts and Locations

Central contacts

Matthew W Harer, MD

434-243-9470mwh9g@virginia.edu

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Matthew W Harer, MD

434-243-9470mwh9g@virginia.edu

Principal Investigator:

Jennifer Charlton, MD

More Information

Sponsor

Matthew Harer, MD

Last update posted

May 12, 2016

Last verified

May, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Matthew Harer, MD on 2016-05-12.