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NCT04354467 · ClinicalTrials.gov registry record

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

A clinical trial of Acute Kidney Injury and Neonatal, sponsored by University of Alabama at Birmingham.

Completed
Registry status
148
Enrollment target
2
Study locations

NCT04354467: Completed study of Acute Kidney Injury and Neonatal, sponsored by University of Alabama at Birmingham.

NCT04354467 is a study of Acute Kidney Injury and Neonatal that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 148 participants, below the 2,329-participant average among 74 other Acute Kidney Injury trials with a reported enrollment target (94% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04354467, a study of Acute Kidney Injury and Neonatal, has completed, sponsored by University of Alabama at Birmingham.

COMPLETED
Registry status
148 participants
Enrollment target
2
Study locations

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.

Primary Outcome

NGAL is an early, sensitive, non-invasive urine biomarker for 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
University of Alabama at Birmingham

1,160 total trials

What the finished NCT04354467 record still lists

NCT04354467 is an observational study that tracks outcomes without assigning an intervention. The registered 148 participants enrollment target is mid-sized for trials with a published cap, below the 2,329-participant average among 74 other Acute Kidney Injury trials with a reported enrollment target (94% lower).

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.

NCT04354467 reports a single indexed study location in Alabama, Ohio.

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.

What interventions are being tested in trial NCT04354467?

The interventions under investigation include: urine neutrophil gelatinase -associated lipocalin (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT04354467?

This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.

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.

Similar trials for Acute Kidney Injury

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04354467's enrollment target sits among peer trials

148 38th of 74 higher than 37 of 74 other Acute Kidney Injury trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Acute Kidney Injury trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04354467, the US trial registry maintained by the National Library of Medicine. NCT04354467 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.