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

The University of Alabama at Birmingham logo

The University of Alabama at Birmingham

Status

Completed

Conditions

Acute Kidney Injury
Nephrotoxicity
Neonatal

Treatments

Diagnostic Test: urine neutrophil gelatinase -associated lipocalin

Study type

Observational

Funder types

Other

Identifiers

NCT04354467
300000362

Details and patient eligibility

About

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.

Full 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.

Enrollment

148 patients

Sex

All

Ages

Under 1 year old

Volunteers

No Healthy Volunteers

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

Trial design

148 participants in 1 patient group

Neonates exposed to Nephrotoxic Medications
Description:
Neonates exposed to Nephrotoxic Medications as defined by the NINJA inclusion criteria
Treatment:
Diagnostic Test: urine neutrophil gelatinase -associated lipocalin

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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