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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04354467

Enrollment

148

Registered

2020-04-21

Start date

2019-01-28

Completion date

2023-12-30

Last updated

2024-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury, Neonatal, Nephrotoxicity

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.

Interventions

DIAGNOSTIC_TESTurine neutrophil gelatinase -associated lipocalin

urine biomarker is measured and batched procesessed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 1 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026