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COMPLETED

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

NCT04354467 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DIAGNOSTIC_TEST urine neutrophil gelatinase -associated lipocalin

Study Locations (2)

Alabama

  • Children's of Alabama — Birmingham

Ohio

  • Cincinnati Children's Hospital Medical Center — Cincinnati

Trial Details

FieldValue
Enrollment Target 148 participants
Start Date 2019-01-28
Est. Completion 2023-12-30

Sponsor

University of Alabama at Birmingham

1,315 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04354467

The ClinicalTrials.gov registry entry for NCT04354467 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 148 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,315 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Acute Kidney Injury appearing as the primary indexed condition, and to 1 intervention — of which urine neutrophil gelatinase -associated lipocalin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04354467 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Alabama, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04354467 about?

NCT04354467 is a clinical study titled "Assessment of Urinary Neutrophil Gelatinase-Associated Lipocalin to Predict AKI in the NICU". 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...

What is the current status of trial NCT04354467?

This trial is currently completed. The enrollment target is 148 participants. The study started on 2019-01-28. Estimated completion is 2023-12-30.

What conditions does trial NCT04354467 study?

This clinical trial studies the following conditions: Acute Kidney Injury, Neonatal, Nephrotoxicity. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04354467?

The interventions under investigation include: urine neutrophil gelatinase -associated lipocalin (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04354467?

This trial is sponsored by University of Alabama at Birmingham, which has 1,315 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04354467 being conducted?

This trial has 2 study locations across Alabama, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial