Follow-up of AKI in Neonates During Childhood Years | NCT02306642

Studies
Follow-up of AKI in Neonates During Childhood Years

NCT02306642

Sponsor

Matthew Harer, MD

Status

Unknown status

Last Update Posted

May 12, 2016Estimated

Enrollment

80Estimated

Phase

Not provided

Conditions

Neonatal Acute Kidney Injury
Childhood Chronic Kidney Disease

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2014

Primary Completion Date

Mar 2017Estimated

Completion Date

Jun 2017Estimated

First Submitted Date

Dec 1, 2014

First Submission Date that Met QC Criteria

Dec 2, 2014

First Posted Date

Dec 3, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 10, 2016

Last Update Posted Date

May 12, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Matthew Harer, MD, Neonatal-Perinatal Medicine Fellow, MD, University of VirginiaSponsor-Investigator

Lead Sponsor

Matthew Harer, MDOTHER

Collaborators

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Growth	Evaluation of height, weight and BMI	Age 2-6 years
Kidney Size	Evaluation of kidney size	Age 2-6 years

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

7 Years

Standard Ages

Child

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Matthew W Harer, MD	Contact	434-243-9470		mwh9g@virginia.edu

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Virginia	Recruiting	Charlottesville	Virginia	22908	United States