Assessment of Urinary Neutrophil Gelatinase-Associated Lipocalin to Predict AKI in the NICU

Completed

Conditions studied: Acute Kidney Injury, Nephrotoxicity, Neonatal

In brief

Nephrotoxic medication (NTMx) exposure is one of the most commonly cited causes of acute kidney injury (AKI) in hospitalized children, and is the primary cause of AKI in 16% of cases. Through initial work at UAB/Children's of Alabama Hospital, NTMx exposure was found to be potentially modifiable and the associated AKI is an avoidable adverse safety event. Currently, only serum Creatinine monitoring is available to monitor for NTMx-associated AKI. The hypothesis of this NINJA NGAL study is that urine NGAL is highly sensitive to detect NTMx-associated AKI. UAB/Children's of Alabama is bringing urine NGAL measurement to the infants in the NICU to detect NTMX-associated AKI.

Key facts

Study ID

NCT04354467

Run by

University of Alabama at Birmingham

People needed

148

Starts

2019-01-28

Expected to finish

2023-12-30

Last updated by the study team

2024-01-05

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Less than 4 days of age
• Currently being treated for a urinary tract infection
• Presence of an acute kidney injury prior to enrollment

Where it is running

• Children's of Alabama — Birmingham, Alabama, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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