Acute Kidney Injury in Premature Infants

This study has been completed.
Sponsor:
Collaborator:
National Kidney Foundation
Information provided by:
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00573079
First received: December 11, 2007
Last updated: February 1, 2011
Last verified: February 2011
  Purpose

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
Acute Kidney Injury

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Acute Kidney Injury in Premature Infants

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Characterize the incidence and risk factors in critically ill premature infants [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 237
Study Start Date: December 2007
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Observation
Premature infants in the NICU; 500-1500g birthweight, >=25 weeks gestation

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Premature Infants 500-1500grams birthweight >=25 weeks gestation

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00573079

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

No publications provided by University of Alabama at Birmingham

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David Askenazi, UAB
ClinicalTrials.gov Identifier: NCT00573079     History of Changes
Other Study ID Numbers: X070926014
Study First Received: December 11, 2007
Last Updated: February 1, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
Kidney
Infants

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

ClinicalTrials.gov processed this record on September 16, 2014