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Completed

NCT Number: NCT04354467

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 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.

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Neonatal Nephrotoxicity Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

Up to 1 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's of Alabama, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

urine neutrophil gelatinase -associated lipocalin

Diagnostic Test

urine biomarker is measured and batched procesessed

Other names: urine NGAL

Primary outcomes

  1. Percentage of patients with elevated urine NGAL

    Time frame: Daily for one week after meeting criteria for nephrotoxic medication exposure

    NGAL is an early, sensitive, non-invasive urine biomarker for AKI.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Children's Hospital Medical Center, Cincinnati

Registry information

Official study 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)

Important dates

Study start
2019
Primary completion
2020
Study completion
2023
First posted
Apr 21, 2020
Registry last updated
Jan 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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