Acute Kidney Injury in Neonates | NCT00572715

Studies
Acute Kidney Injury in Neonates

NCT00572715

Sponsor

University of Alabama at Birmingham

Status

Withdrawn

Last Update Posted

May 14, 2020Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Acute Kidney Injury

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Investigator's decision:Did not open to enrollment

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Jan 31, 2010

Completion Date

Jan 31, 2010Actual

First Submitted Date

Dec 11, 2007

First Submission Date that Met QC Criteria

Dec 12, 2007

First Posted Date

Dec 13, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 12, 2020

Last Update Posted Date

May 14, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

David Askenazi, Principal Investigator, University of Alabama at BirminghamPrincipal Investigator

Lead Sponsor

University of Alabama at BirminghamOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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 term neonates, 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 neonates 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 neonates.

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Characterize the incidence and risk factors of AKI in critically ill neonates		2 years

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Minute

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35233	United States

Condition Browse Module

MeSH Terms

ID	Term
D058186	Acute Kidney Injury

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

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Browse Branches

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