- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04354467
Assessment of Urinary Neutrophil Gelatinase-Associated Lipocalin to Predict AKI in the NICU
Assessment of Urinary Neutrophil Gelatinase-Associated Lipocalin (NGAL) Ito Predict Acute Kidney Injury (AKI) in the NICU in Infants Receiving Multiple Nephrotoxic Medications (NICU NINJA NGAL)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Nephrotoxic medication-induced acute kidney injury (NTM-AKI) is a relevant yet underdiagnosed morbidity in the neonatal intensive care unit (NICU).
Up to 87% of very low birth weight infants are exposed to at least one nephrotoxic medication (NTM). NTM-AKI is associated with poor short and long-term outcomes.
Presently, no treatments exist for AKI beyond supportive care.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Alabama
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Birmingham, Alabama, United States, 35233
- Children's of Alabama
-
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Ohio
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Cincinnati, Ohio, United States, 45229
- Cincinnati Children's Hospital Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
all NICU inpatients under 1 year of age; greater than 4 days of age that are
- Receiving 3 or more nephrotoxic medications on the same day OR
- Receiving 3 or more days of an intravenous aminoglycoside or vancomycin
Exclusion Criteria:
Less than 4 days of age
- Currently being treated for a urinary tract infection
- Presence of an acute kidney injury prior to enrollment
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Neonates exposed to Nephrotoxic Medications
Neonates exposed to Nephrotoxic Medications as defined by the NINJA inclusion criteria
|
urine biomarker is measured and batched procesessed
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of patients with elevated urine NGAL
Time Frame: Daily for one week after meeting criteria for nephrotoxic medication exposure
|
NGAL is an early, sensitive, non-invasive urine biomarker for AKI.
|
Daily for one week after meeting criteria for nephrotoxic medication exposure
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: David Askenazi, University of Alabama at Birmingham
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 300000362
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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