Clinical trial NCT04354467: Assessment of Urinary Neutrophil Gelatinase-Associated Lipocalin to Predict AKI in the NICU
Official title: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Nephrotoxicity
Neonatal
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Children's Hospital Medical Center, Cincinnati
First posted: 2020-04-21
Enrollment: 148
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Admitted to Neonatal Intensive Care Unit

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients with elevated urine NGAL
timeFrame: Daily for one week after meeting criteria for nephrotoxic medication exposure
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Children's of Alabama
state: Alabama
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: University of Alabama at Birmingham
name: David Askenazi
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stoops C, Gavigan H, Krallman K, Anderson N, Griffin R, Slagle C, House S, Goldstein SL, Askenazi DJ. The Utility of Urinary NGAL as an Alternative for Serum Creatinine to Detect Acute Kidney Injury in Infants Exposed to Nephrotoxic Medications in the Neonatal Intensive Care Unit. Neonatology. 2024;121(2):203-212. doi: 10.1159/000535322. Epub 2023 Dec 27.