NCT00572715

Brief Summary

Our first aim is to describe how common a sudden decrease in renal function happens in 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

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

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
2.1 years until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2010

Completed
Last Updated

May 14, 2020

Status Verified

May 1, 2020

Enrollment Period

1 month

First QC Date

December 11, 2007

Last Update Submit

May 12, 2020

Conditions

Acute Kidney Injury

Keywords

kidneyneonates

Outcome Measures

Primary Outcomes (1)

  • Characterize the incidence and risk factors of AKI in critically ill neonates

    2 years

Secondary Outcomes (1)

  • Compare Hospital outcomes of critically ill neonates with and without AKI. Test the ability of known noninvasive urinary biomarkers ability to detect AKI in neonates

    2 years

Study Arms (1)

Observation

Inclusion criteria - Families of infants (birthweight \>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 Criteria

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

Inclusion criteria - Families of infants (birthweight \>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

You may qualify if:

  • Families of infants (birthweight \>1500g) be asked to participate in the study.

You may not qualify if:

  • Infants with prenatal renal ultrasound diagnosis of severe hydronephrosis or other known renal abnormalities will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases
0

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

January 1, 2010

Primary Completion

January 31, 2010

Study Completion

January 31, 2010

Last Updated

May 14, 2020

Record last verified: 2020-05

Locations

US(1)