CClinicalTrials.gg
Status unknownNCT02306642FANCYUpdated May 12, 2016

Follow-up of AKI in Neonates During Childhood Years

An observational study in Neonatal Acute Kidney Injury and Childhood Chronic Kidney Disease, sponsored by Matthew Harer, MD. Status unknown at 1 site in United States. Open to participants aged 2 Years to 7 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-05-12.

Sponsored by Matthew Harer, MD · Observational

The sponsor has not verified this record recently (last verified May 2016), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
80
Ages
2 Years to 7 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Neonatal Acute Kidney Injury
  • Childhood Chronic Kidney Disease
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's planned enrollment of 80 is below the median of 192 across 1,033 observational studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

This is the only study on the registry with Matthew Harer, MD as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 7 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Children born prematurely less than 1500 grams who stayed in the University of Virginia NICU.

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

Exclusion Criteria:

  • Patients with Congenital Anomalies of the Kidney and Urinary Tract
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
80 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Composite Abnormality

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

    Time frame: Age 2-7 years

Secondary outcomes

  1. Growth

    Evaluation of height, weight and BMI

    Time frame: Age 2-6 years

  2. Kidney Size

    Evaluation of kidney size

    Time frame: Age 2-6 years

  3. Urinary Biomarkers

    Evaluation of urine for biomarkers which can be used to detect early chronic kidney disease

    Time frame: Age 2-6 years

07

Study locations

1 of 1 sites recruiting
  • University of Virginia
    Charlottesville, Virginia 22908, United States
    • Matthew W Harer, MD · Contact · mwh9g@virginia.edu · 434-243-9470
    • Jennifer Charlton, MD · Principal investigator
    • Matthew Harer, MD · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02306642
Lead sponsor
Matthew Harer, MD
Responsible party
Matthew Harer, MD (Neonatal-Perinatal Medicine Fellow, MD, University of Virginia) — Sponsor-investigator
First posted
Dec 3, 2014
Start date
Dec 2014
Primary completion
Mar 2017 (estimated)
Completion
Jun 2017 (estimated)
Last update
May 12, 2016

Study contacts

Matthew W Harer, MD
Contact
mwh9g@virginia.edu
434-243-9470
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion