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

Completed

• Conditions: Acute Kidney Injury; Neonatal; Nephrotoxicity
• Interventions: Diagnostic Test: urine neutrophil gelatinase -associated lipocalin

• Registration Number: NCT04354467
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-01-28
• Study First Submitted: 2020-04-16
• Study First Submitted QC: 2020-04-16
• Study First Posted: 2020-04-21
• Primary Completion: 2020-12-30
• Study Completion: 2023-12-30
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-03
• Last Update Posted: 2024-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Neonates exposed to Nephrotoxic Medications	urine neutrophil gelatinase -associated lipocalin	Neonates exposed to Nephrotoxic Medications as defined by the NINJA inclusion criteria

Primary Outcome Measures

Name	Time	Method
Percentage of patients with elevated urine NGAL	Daily for one week after meeting criteria for nephrotoxic medication exposure	NGAL is an early, sensitive, non-invasive urine biomarker for AKI.

Trial Locations

Locations (2)

Children's of Alabama; 🇺🇸 Birmingham, Alabama, United States

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States