Follow-up of AKI in Neonates During Childhood Years

NCT ID: NCT02306642

Last Updated: 2016-05-12

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2017-06-30

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 Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Term No Acute Kidney Injury

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

No interventions assigned to this group

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Matthew Harer, MD

OTHER

Sponsor Role: lead

Responsible Party

Matthew Harer, MD

Neonatal-Perinatal Medicine Fellow, MD

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

University of Virginia

Charlottesville, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Matthew W Harer, MD

Role: CONTACT

mwh9g@virginia.edu

434-243-9470

Facility Contacts

Matthew W Harer, MD

Role: primary

mwh9g@virginia.edu

434-243-9470

Other Identifiers

17540

Identifier Type: -

Identifier Source: org_study_id