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

• Sponsor: University of Alabama at Birmingham (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04354467
• Collaborator: Children's Hospital Medical Center, Cincinnati (Other)
• Enrollment: 100
• Locations: 2
• Anticipated Duration (Months): 47
• Patients Per Site: 50
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury; Nephrotoxicity; Neonatal	Drug: Acute kidney Injury due to nephrotoxic medications in the NICU

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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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)
• Actual Study Start Date: Jan 28, 2019
• Actual Primary Completion Date: Dec 30, 2020
• Anticipated Study Completion Date: Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Acute Kidney Injury due to Nephrotoxic medication	Drug: Acute kidney Injury due to nephrotoxic medications in the NICU; AKI will be defined using the KDIGO AKI definition
No Acute Kidney Injury due to Nephrotoxic Medications	Drug: Acute kidney Injury due to nephrotoxic medications in the NICU; AKI will be defined using the KDIGO AKI definition

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 1 Year
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's of Alabama	Birmingham	Alabama	United States	35233
2	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45229

Sponsors and Collaborators

• University of Alabama at Birmingham
• Children's Hospital Medical Center, Cincinnati

Investigators

• Principal Investigator: David Askenazi, University of Alabama at Birmingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: David Askenazi, Principal Investigator, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT04354467
• Other Study ID Numbers: 300000362
• First Posted: Apr 21, 2020
• Last Update Posted: May 2, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Acute Kidney Injury

Study Results

No Results Posted as of May 2, 2022