Follow-up of AKI in Neonates During Childhood Years

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02306642

Acronym

FANCY

Enrollment

Registered

2014-12-03

Start date

2014-12-31

Completion date

2017-06-30

Last updated

2016-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood Chronic Kidney Disease, Neonatal Acute Kidney Injury

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Years to 7 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

United States

Contacts

Primary ContactMatthew W Harer, MD

mwh9g@virginia.edu434-243-9470

Outcome results