Acute Kidney Injury in Premature Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00573079
Recruitment Status : Completed
First Posted : December 13, 2007
Last Update Posted : February 3, 2011
National Kidney Foundation
Information provided by:
University of Alabama at Birmingham

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.

Condition or disease
Acute Kidney Injury

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 Type : Observational
Actual Enrollment : 237 participants
Time Perspective: Prospective
Official Title: Acute Kidney Injury in Premature Infants
Study Start Date : December 2007
Actual Primary Completion Date : December 2010

Premature infants in the NICU; 500-1500g birthweight, >=25 weeks gestation

Primary Outcome Measures :
  1. Characterize the incidence and risk factors in critically ill premature infants [ Time Frame: 2 years ]

Secondary Outcome Measures :
  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 [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Premature Infants 500-1500grams birthweight >=25 weeks gestation

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00573079

United States, Alabama
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
University of Alabama at Birmingham
National Kidney Foundation
Principal Investigator: David Askenazi, MD University of Alabama at Birmingham

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: David Askenazi, UAB Identifier: NCT00573079     History of Changes
Other Study ID Numbers: X070926014
First Posted: December 13, 2007    Key Record Dates
Last Update Posted: February 3, 2011
Last Verified: February 2011

Keywords provided by University of Alabama at Birmingham:

Additional relevant MeSH terms:
Wounds and Injuries
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases