Acute Kidney InjuryNCT00573079
Acute Kidney Injury in Premature Infants
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 premature infants in a neonatal intensive care unit. We also want to see how a sudden loss of renal function affects survival. 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
- 237 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to 31 Dec 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: Premature Infants 500-1500grams birthweight >=25 weeks gestation
Who may be able to join
- 500-1500 grams birthweight
- >=25 weeks gestation
Who cannot join
- infants who do not survive 24 hours of life
- infants with severe congenital abnormalities
Trial locations and contacts
1 site in 1 country.
About this study
Our first Aim is to describe how common a sudden decrease in renal function happens in premature 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 premature infants, 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 premature infants 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 premature infants.
Inclusion criteria - infants (birthweight 500-1500g) 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, Infants
- 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 | Premature infants in the NICU; 500-1500g birthweight, >=25 weeks gestation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize the incidence and risk factors in critically ill premature infants
Measured: 2 years
Secondary outcomes (1)
Compare hospital of premature infants outcomes with and without AKI. Test ability of known noninvasive urinary biomarkers' ability to detect AKI in premature infants
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 startDec 2007
- Primary completion31 Dec 2010
- Study completion31 Dec 2010
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
- Other
- Time perspective
- Prospective
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Kidney Foundation, United States
- Responsible party
- Principal investigator, David Askenazi, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00573079
- Sponsor's protocol ID
- X070926014
- Status last verified
- May 2020
- First submitted
- 11 Dec 2007
- Last updated
- 14 May 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Koralkar R, Ambalavanan N, Levitan EB, McGwin G, Goldstein S, Askenazi D. Acute kidney injury reduces survival in very low birth weight infants. Pediatr Res. 2011 Apr;69(4):354-8. doi: 10.1203/PDR.0b013e31820b95ca.
PubMed 21178824
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 Premature Infants
- ClinicalTrials.gov ID
- NCT00573079
- Acronym / sponsor ID
- X070926014
- Conditions
- Acute Kidney Injury
- Keywords
- Kidney, Infants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Kidney Foundation, United States
- Study start
- Dec 2007
- Primary completion
- 31 Dec 2010 (actual)
- Study completion
- 31 Dec 2010
- 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 premature 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 premature infants, 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 premature infants 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 premature infants.
Inclusion criteria - infants (birthweight 500-1500g) 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 | – | –Premature infants in the NICU; 500-1500g birthweight, >=25 weeks gestation |
Who may qualify
- Ages
- 1 minute and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Premature Infants 500-1500grams birthweight >=25 weeks gestation
Key inclusion criteria (2 listed)
- 500-1500 grams birthweight
- >=25 weeks gestation
Key exclusion criteria (2 listed)
- infants who do not survive 24 hours of life
- infants with severe congenital abnormalities
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 in critically ill premature infants
Time frame: 2 years
1 secondary outcome
Compare hospital of premature infants outcomes with and without AKI. Test ability of known noninvasive urinary biomarkers' ability to detect AKI in premature infants
Time frame: 2 years
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 14 May 2020.
- Derived from this study: PubMed 21178824Koralkar R, Ambalavanan N, Levitan EB, McGwin G, Goldstein S, Askenazi D. Acute kidney injury reduces survival in very low birth weight infants. Pediatr Res. 2011 Apr;69(4):354-8. doi: 10.1203/PDR.0b013e31820b95ca.
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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 2 inclusion and 2 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 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 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?
Characterize the incidence and risk factors in critically ill premature infants (time frame: 2 years). 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 NCT00573079, 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 14 May 2020.