Kidney PerfusionNCT00847951
Ultrasound for Perfusion in Neonates
A study testing 3D Ultrasound Imaging in people with Kidney Perfusion, run by University of Michigan at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 1 day to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Kidney Perfusion
- What is being tested?
- 3D Ultrasound Imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Very low birth weight babies in ICU in stable condition and/or premature babies in ICU in stable condition
Who cannot join
- Unstable very low birth weight/premature babies
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Hospital
Ann Arbor, Michigan, 48109
About this study
Official title: 3D Ultrasound for Perfusion in Neonates
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.
Read the 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.
- Conditions
- Kidney Perfusion
- Being tested
- 3D Ultrasound Imaging
- Keywords
- renal, neonates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Ultrasound ImagingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Renal perfusion in Neonates | Other | Ultrasound scanning with power Doppler is used to determine the fractional blood volume of the kidneys. Receives: Procedure: 3D Ultrasound Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2009 (estimated)
- Study startOct 2008
- Primary completionJan 2012
- Study completionJan 2012
Why it stopped: Study terminated at this time by investigator. Will create new protocol.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney PerfusionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Jonathan Rubin, M.D., University of Michigan
- Investigators
- Jonathan Rubin, MD, Principal investigator, Univeristy of Michigan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00847951
- Sponsor's protocol ID
- HUM00021322
- Status last verified
- Sep 2017
- First submitted
- 17 Feb 2009
- Last updated
- 19 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Ultrasound for Perfusion in Neonates
- ClinicalTrials.gov ID
- NCT00847951
- Acronym / sponsor ID
- HUM00021322
- Conditions
- Kidney Perfusion
- Keywords
- renal, neonates
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study terminated at this time by investigator. Will create new protocol.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Oct 2008 (actual)
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 19 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Renal perfusion in Neonates | Other | Procedure: 3D Ultrasound ImagingUltrasound scanning with power Doppler is used to determine the fractional blood volume of the kidneys. |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Very low birth weight babies in ICU in stable condition and/or premature babies in ICU in stable condition
Key exclusion criteria (1 listed)
- Unstable very low birth weight/premature babies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D Ultrasound ImagingUltrasound 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. | Procedure or surgery | Renal perfusion in Neonates |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Rubin, MD principal investigator
Univeristy of Michigan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D Ultrasound Imaging in people with Kidney Perfusion, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine if ultrasound imaging can accurately help physicians determine if the kidneys are being adequately perfused. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2017.