Acute Kidney InjuryNCT04354467
Assessment of Urinary Neutrophil Gelatinase-Associated Lipocalin to Predict AKI in the NICU
An observational study of Acute Kidney Injury and Nephrotoxicity, run by University of Alabama at Birmingham at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Acute Kidney Injury, Nephrotoxicity, Neonatal
- What is being tested?
- urine neutrophil gelatinase -associated lipocalin
- How many people
- 148 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Jan 2019to 30 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 year
- All sexes
- No healthy volunteers
- Child
Study population: Admitted to Neonatal Intensive Care Unit
Who may be able to join
- 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
Who cannot join
- Less than 4 days of age
- Currently being treated for a urinary tract infection
- Presence of an acute kidney injury prior to enrollment
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's of Alabama
Birmingham, Alabama, 35233
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
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)
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.
Read the 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.
- Conditions
- Acute Kidney Injury, Nephrotoxicity, Neonatal
- Being tested
- urine neutrophil gelatinase -associated lipocalin
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urine neutrophil gelatinase -associated lipocalinDiagnostic test
Also called urine NGAL
urine biomarker is measured and batched procesessed
| Study group | Role | What they receive |
|---|---|---|
| Neonates exposed to Nephrotoxic Medications | Neonates exposed to Nephrotoxic Medications as defined by the NINJA inclusion criteria Receives: Diagnostic Test: urine neutrophil gelatinase -associated lipocalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with elevated urine NGAL
NGAL is an early, sensitive, non-invasive urine biomarker for AKI.
Measured: Daily for one week after meeting criteria for nephrotoxic medication exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start28 Jan 2019
- Primary completion30 Dec 2020
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Medical Center, Cincinnati
- Responsible party
- Principal investigator, David Askenazi, University of Alabama at Birmingham
- Investigators
- David Askenazi, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04354467
- Sponsor's protocol ID
- 300000362
- Status last verified
- Jan 2024
- First submitted
- 16 Apr 2020
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: upon request
Publications
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.
PubMed 38151013
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04354467
- Acronym / sponsor ID
- 300000362
- Conditions
- Acute Kidney Injury, Nephrotoxicity, Neonatal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Children's Hospital Medical Center, Cincinnati
- Study start
- 28 Jan 2019 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 21 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neonates exposed to Nephrotoxic Medications | – | Diagnostic Test: urine neutrophil gelatinase -associated lipocalinNeonates exposed to Nephrotoxic Medications as defined by the NINJA inclusion criteria |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Admitted to Neonatal Intensive Care Unit
Key inclusion criteria (3 listed)
- all NICU inpatients under 1 year of age; greater than 4 days of age that are
Key exclusion criteria (3 listed)
- Less than 4 days of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| urine neutrophil gelatinase -associated lipocalinAlso: urine NGALurine biomarker is measured and batched procesessed | Diagnostic test | Neonates exposed to Nephrotoxic Medications |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Results publication: PubMed 38151013Stoops 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.
- Individual participant dataSharing planned: Yes. upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Askenazi principal investigator
University of Alabama at Birmingham
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Nephrotoxicity, run by University of Alabama at Birmingham at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with elevated urine NGAL (time frame: Daily for one week after meeting criteria for nephrotoxic medication exposure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04354467, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.