Assessment of Urinary Neutrophil Gelatinase-Associated Lipocalin to Predict AKI in the NICU
1 other identifier
observational
148
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2019
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 28, 2019
CompletedFirst Submitted
Initial submission to the registry
April 16, 2020
CompletedFirst Posted
Study publicly available on registry
April 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2023
CompletedJanuary 5, 2024
January 1, 2024
1.9 years
April 16, 2020
January 3, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Neonates exposed to Nephrotoxic Medications
Neonates exposed to Nephrotoxic Medications as defined by the NINJA inclusion criteria
Interventions
urine biomarker is measured and batched procesessed
Eligibility Criteria
Admitted to Neonatal Intensive Care Unit
You may qualify if:
- 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
You may not qualify if:
- Less than 4 days of age
- Currently being treated for a urinary tract infection
- Presence of an acute kidney injury prior to enrollment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Children's of Alabama
Birmingham, Alabama, 35233, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Related Publications (1)
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.
PMID: 38151013RESULT
Biospecimen
Urine
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Askenazi
University of Alabama at Birmingham
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 16, 2020
First Posted
April 21, 2020
Study Start
January 28, 2019
Primary Completion
December 30, 2020
Study Completion
December 30, 2023
Last Updated
January 5, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, CSR
- Time Frame
- in 2025 for 4 years
upon request