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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

148 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-28

Study Completion Date

2023-12-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acute Kidney Injury Nephrotoxicity Neonatal

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Neonates exposed to Nephrotoxic Medications

Neonates exposed to Nephrotoxic Medications as defined by the NINJA inclusion criteria

urine neutrophil gelatinase -associated lipocalin

Intervention Type DIAGNOSTIC_TEST

urine biomarker is measured and batched procesessed

Interventions

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urine neutrophil gelatinase -associated lipocalin

urine biomarker is measured and batched procesessed

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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urine NGAL

Eligibility Criteria

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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