NCT00573079

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
237

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

December 11, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 13, 2007

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2010

Completed
Last Updated

May 14, 2020

Status Verified

May 1, 2020

Enrollment Period

3.1 years

First QC Date

December 11, 2007

Last Update Submit

May 12, 2020

Conditions

Acute Kidney Injury

Keywords

KidneyInfants

Outcome Measures

Primary Outcomes (1)

  • Characterize the incidence and risk factors in critically ill premature infants

    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

    2 years

Study Arms (1)

Observation

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

Eligibility Criteria

Age1 Minute+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • grams birthweight
  • \>=25 weeks gestation

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UAB

Birmingham, Alabama, 35233, United States

Location

Related Publications (1)

  • 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.

    PMID: 21178824DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 11, 2007

First Posted

December 13, 2007

Study Start

December 1, 2007

Primary Completion

December 31, 2010

Study Completion

December 31, 2010

Last Updated

May 14, 2020

Record last verified: 2020-05

Locations

US(1)