Acute Kidney InjuryNCT00572715
Acute Kidney Injury in Neonates
An observational study of Acute Kidney Injury, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
Our first aim is to describe how common a sudden decrease in renal function happens in infants in a neonatal intensive care unit. We also want to see how a sudden loss of renal function affects survival. Finally, we will explore non-invasive markers to identify a sudden decrease in renal function from urinary samples. Read more about this study
- Who is it for?
- Ages 1 minute and older
- Conditions the study is for
- Acute Kidney Injury
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to 31 Jan 2010
- 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 1 minute and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Inclusion criteria - Families of infants (birthweight >1500g) be asked to participate in the study. Exclusion criteria - Infants with prenatal renal ultrasound diagnosis of severe hydronephrosis or other known renal abnormalities will be excluded
Who may be able to join
- Families of infants (birthweight >1500g) be asked to participate in the study.
Who cannot join
- Infants with prenatal renal ultrasound diagnosis of severe hydronephrosis or other known renal abnormalities will be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
Our first aim is to describe how common a sudden decrease in renal function happens in infants in a neonatal intensive care unit. We also want to see how a sudden loss of renal function affects survival. Finally, we will explore non-invasive markers to identify a sudden decrease in renal function from urinary samples.
Read the detailed description
Advancements in the field of peri-natal medicine has improved the survival of critically ill neonates but yet many still do not survive, and many more are left with long-term damage to vital organ systems. Very little data is available on the impact that acute kidney injury (AKI) has on survival in term neonates, but adult and pediatric studies that show that even mild AKI independently impacts survival after correcting for severity of illness. The role that AKI impacts survival in neonates is likely to be greater than adults as this acute injury occurs in context of impaired and ongoing kidney development.
Our ability to improve outcomes in children and adults with AKI has been hampered by the inability to recognize AKI early in the disease process. Thus, the work on early non-invasive biomarkers of renal injury has brought great optimism to the field of AKI. Serum and urinary levels of neutrophil gelatinase-associated lipocalin (NGAL), urinary interleukin 18 (IL-18) others are markedly elevated several hours after AKI as opposed to serum creatinine which takes days to rise after the inciting event. Early non-invasive biomarkers of AKI have not been tested in neonates.
Inclusion criteria - Families of infants (birthweight >1500g) be asked to participate in the study.
Exclusion criteria - Infants with prenatal renal ultrasound diagnosis of severe hydronephrosis or other known renal abnormalities will be excluded
- Conditions
- Acute Kidney Injury
- Keywords
- kidney, neonates
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Observation | Inclusion criteria - Families of infants (birthweight >1500g) be asked to participate in the study. Exclusion criteria - Infants with prenatal renal ultrasound diagnosis of severe hydronephrosis or other known renal abnormalities will be excluded |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize the incidence and risk factors of AKI in critically ill neonates
Measured: 2 years
Secondary outcomes (1)
Compare Hospital outcomes of critically ill neonates with and without AKI. Test the ability of known noninvasive urinary biomarkers ability to detect AKI in neonates
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2007 (estimated)
- Study startJan 2010
- Primary completion31 Jan 2010
- Study completion31 Jan 2010
Why it stopped: Investigator's decision:Did not open to enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Askenazi, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00572715
- Sponsor's protocol ID
- X070927001
- Status last verified
- May 2020
- First submitted
- 11 Dec 2007
- Last updated
- 14 May 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Kidney Injury in Neonates
- ClinicalTrials.gov ID
- NCT00572715
- Acronym / sponsor ID
- X070927001
- Conditions
- Acute Kidney Injury
- Keywords
- kidney, neonates
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Investigator's decision:Did not open to enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- 31 Jan 2010
- Study completion
- 31 Jan 2010 (actual)
- First posted
- 13 Dec 2007 (estimated)
- 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.
Our first aim is to describe how common a sudden decrease in renal function happens in infants in a neonatal intensive care unit. We also want to see how a sudden loss of renal function affects survival. Finally, we will explore non-invasive markers to identify a sudden decrease in renal function from urinary samples.
Detailed description
Advancements in the field of peri-natal medicine has improved the survival of critically ill neonates but yet many still do not survive, and many more are left with long-term damage to vital organ systems. Very little data is available on the impact that acute kidney injury (AKI) has on survival in term neonates, but adult and pediatric studies that show that even mild AKI independently impacts survival after correcting for severity of illness. The role that AKI impacts survival in neonates is likely to be greater than adults as this acute injury occurs in context of impaired and ongoing kidney development.
Our ability to improve outcomes in children and adults with AKI has been hampered by the inability to recognize AKI early in the disease process. Thus, the work on early non-invasive biomarkers of renal injury has brought great optimism to the field of AKI. Serum and urinary levels of neutrophil gelatinase-associated lipocalin (NGAL), urinary interleukin 18 (IL-18) others are markedly elevated several hours after AKI as opposed to serum creatinine which takes days to rise after the inciting event. Early non-invasive biomarkers of AKI have not been tested in neonates.
Inclusion criteria - Families of infants (birthweight >1500g) be asked to participate in the study.
Exclusion criteria - Infants with prenatal renal ultrasound diagnosis of severe hydronephrosis or other known renal abnormalities will be excluded
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation | – | –Inclusion criteria - Families of infants (birthweight >1500g) be asked to participate in the study. Exclusion criteria - Infants with prenatal renal ultrasound diagnosis of severe hydronephrosis or other known renal abnormalities will be excluded |
Who may qualify
- Ages
- 1 minute and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Inclusion criteria - Families of infants (birthweight >1500g) be asked to participate in the study. Exclusion criteria - Infants with prenatal renal ultrasound diagnosis of severe hydronephrosis or other known renal abnormalities will be excluded
Key inclusion criteria (1 listed)
- Families of infants (birthweight >1500g) be asked to participate in the study.
Key exclusion criteria (1 listed)
- Infants with prenatal renal ultrasound diagnosis of severe hydronephrosis or other known renal abnormalities will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Characterize the incidence and risk factors of AKI in critically ill neonates
Time frame: 2 years
1 secondary outcome
Compare Hospital outcomes of critically ill neonates with and without AKI. Test the ability of known noninvasive urinary biomarkers ability to detect AKI in neonates
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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, run by University of Alabama at Birmingham at 1 site 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 14 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was withdrawn before enrolling participants, so there are no results.
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?
Characterize the incidence and risk factors of AKI in critically ill neonates (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2020.