Neonatal Acute Kidney InjuryFANCYNCT02306642
Follow-up of AKI in Neonates During Childhood Years
An observational study of Neonatal Acute Kidney Injury and Childhood Chronic Kidney Disease, run by Matthew Harer, MD at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 2 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Neonatal Acute Kidney Injury, Childhood Chronic Kidney Disease
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children born prematurely less than 1500 grams who stayed in the University of Virginia NICU.
Who may be able to join
- 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
Who cannot join
- Patients with Congenital Anomalies of the Kidney and Urinary Tract
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22908
Matthew W Harer, MD, 434-243-9470, mwh9g@virginia.edu
Jennifer Charlton, MD
About this study
Official title: Long Term Follow-up of Acute Kidney Injury in Very Low Birth Weight Infants
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Abnormality
Either eGFR > 90, urine protein/creatinine > 0.2, or BP > 95th percentile for age and height
Measured: Age 2-7 years
Secondary outcomes (3)
Growth
Evaluation of height, weight and BMI
Measured: Age 2-6 years
Kidney Size
Evaluation of kidney size
Measured: Age 2-6 years
Urinary Biomarkers
Evaluation of urine for biomarkers which can be used to detect early chronic kidney disease
Measured: Age 2-6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionMar 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Matthew Harer, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Matthew Harer, MD, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02306642
- Sponsor's protocol ID
- 17540
- Acronym
- FANCY
- Status last verified
- May 2016
- First submitted
- 1 Dec 2014
- Last updated
- 12 May 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Follow-up of Acute Kidney Injury in Very Low Birth Weight Infants
- ClinicalTrials.gov ID
- NCT02306642
- Acronym / sponsor ID
- FANCY / 17540
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Matthew Harer, MDUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 3 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children born prematurely less than 1500 grams who stayed in the University of Virginia NICU.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with Congenital Anomalies of the Kidney and Urinary Tract
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Composite Abnormality
Time frame: Age 2-7 years
Either eGFR > 90, urine protein/creatinine > 0.2, or BP > 95th percentile for age and height
3 secondary outcomes
Growth
Time frame: Age 2-6 years
Kidney Size
Time frame: Age 2-6 years
Urinary Biomarkers
Time frame: Age 2-6 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Acute Kidney Injury and Childhood Chronic Kidney Disease, run by Matthew Harer, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthew W Harer, MD (434-243-9470, mwh9g@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Abnormality (time frame: Age 2-7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2016.