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Clinical Trials/NCT00573079
NCT00573079
Completed
Not Applicable

Acute Kidney Injury in Premature Infants

University of Alabama at Birmingham1 site in 1 country237 target enrollmentDecember 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Kidney Injury
Sponsor
University of Alabama at Birmingham
Enrollment
237
Locations
1
Primary Endpoint
Characterize the incidence and risk factors in critically ill premature infants
Status
Completed
Last Updated
5 years ago

Overview

Brief 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. 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

Registry
clinicaltrials.gov
Start Date
December 2007
End Date
December 31, 2010
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

David Askenazi

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

Inclusion Criteria

  • 500-1500 grams birthweight
  • \>=25 weeks gestation

Exclusion Criteria

  • infants who do not survive 24 hours of life
  • infants with severe congenital abnormalities

Outcomes

Primary Outcomes

Characterize the incidence and risk factors in critically ill premature infants

Time Frame: 2 years

Secondary Outcomes

  • Compare hospital of premature infants outcomes with and without AKI. Test ability of known noninvasive urinary biomarkers' ability to detect AKI in premature infants(2 years)

Study Sites (1)

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