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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00847951
Other study ID # HUM00021322
Secondary ID
Status Withdrawn
Phase N/A
First received February 17, 2009
Last updated September 18, 2017
Start date October 2008
Est. completion date January 2012

Study information

Verified date September 2017
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness of renal ultrasound to check kidney perfusion in premature and/or very low birth weight babies.


Description:

The purpose of this study is to evaluate the effectiveness of 3D (3 dimensional)renal ultrasound to check kidney perfusion (to see if the kidney is receiving enough blood flow to function as it should) in premature and/or very low birth weight babies.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date January 2012
Est. primary completion date January 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 28 Days
Eligibility Inclusion Criteria:

- Very low birth weight babies in ICU in stable condition and/or premature babies in ICU in stable condition

Exclusion Criteria:

- Unstable very low birth weight/premature babies

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
3D Ultrasound Imaging
Ultrasound scanning with power Doppler is used to determine the fractional blood volume of the kidneys in pre-mature and/or very low birth weight babies. This is a measure of perfusion and an indication of how well the kidneys are working.

Locations

Country Name City State
United States University of Michigan Hospital Ann Arbor Michigan

Sponsors (2)

Lead Sponsor Collaborator
University of Michigan National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary To determine if ultrasound imaging can accurately help physicians determine if the kidneys are being adequately perfused. Fractional blood volume was determined as a way to measure kidney perfusion. Adequate perfusion indicates that the kidneys are working and might indicate if a baby was responding to a specific treatment or not. 1 year