We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ultrasound for Perfusion in Neonates

This study has been withdrawn prior to enrollment.
(Study terminated at this time by investigator. Will create new protocol.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00847951
First Posted: February 19, 2009
Last Update Posted: September 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Jonathan Rubin, M.D., University of Michigan
  Purpose
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 Intervention
Kidney Perfusion Procedure: 3D Ultrasound Imaging

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 3D Ultrasound for Perfusion in Neonates

Resource links provided by NLM:


Further study details as provided by Jonathan Rubin, M.D., University of Michigan:

Primary Outcome Measures:
  • 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.


Enrollment: 0
Actual Study Start Date: October 2008
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

Responsible Party: Jonathan Rubin, M.D., Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT00847951     History of Changes
Other Study ID Numbers: HUM00021322
First Submitted: February 17, 2009
First Posted: February 19, 2009
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