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Ultrasound for Perfusion in Neonates

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ClinicalTrials.gov Identifier: NCT00847951
Recruitment Status : Withdrawn (Study terminated at this time by investigator. Will create new protocol.)
First Posted : February 19, 2009
Last Update Posted : September 19, 2017
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Jonathan Rubin, M.D., University of Michigan

Brief 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.

Condition or disease Intervention/treatment Phase
Kidney Perfusion Procedure: 3D Ultrasound Imaging Not Applicable

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 3D Ultrasound for Perfusion in Neonates
Actual Study Start Date : October 2008
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
U.S. FDA Resources

Arm Intervention/treatment
Renal perfusion in Neonates
Ultrasound scanning with power Doppler is used to determine the fractional blood volume of the kidneys.
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.



Primary Outcome Measures :
  1. To determine if ultrasound imaging can accurately help physicians determine if the kidneys are being adequately perfused. [ Time Frame: 1 year ]
    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.



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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00847951


Locations
United States, Michigan
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
National Institutes of Health (NIH)
Investigators
Principal Investigator: Jonathan Rubin, MD Univeristy of Michigan Hospital

Responsible Party: Jonathan Rubin, M.D., Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT00847951     History of Changes
Other Study ID Numbers: HUM00021322
First Posted: February 19, 2009    Key Record Dates
Last Update Posted: September 19, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jonathan Rubin, M.D., University of Michigan:
renal
neonates