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| Name | Class |
|---|---|
| Children's Hospital Medical Center, Cincinnati | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neonates exposed to Nephrotoxic Medications | Neonates exposed to Nephrotoxic Medications as defined by the NINJA inclusion criteria |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| urine neutrophil gelatinase -associated lipocalin | Diagnostic Test | urine biomarker is measured and batched procesessed |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with elevated urine NGAL | NGAL is an early, sensitive, non-invasive urine biomarker for AKI. | Daily for one week after meeting criteria for nephrotoxic medication exposure |
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Inclusion Criteria:
all NICU inpatients under 1 year of age; greater than 4 days of age that are
Exclusion Criteria:
Less than 4 days of age
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Admitted to Neonatal Intensive Care Unit
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| Name | Affiliation | Role |
|---|---|---|
| David Askenazi | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's of Alabama | Birmingham | Alabama | 35233 | United States | ||
| Cincinnati Children's Hospital Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38151013 | Result | 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. |
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upon request
in 2025 for 4 years
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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Urine
| Cincinnati |
| Ohio |
| 45229 |
| United States |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |