Neonatal Intensive CareCHNCT01610622
Estimation of Cardiac Output in Neonatal ICU Using an Ultrasound Dilution Technique
An observational study of Neonatal Intensive Care, run by Transonic Systems Inc. at 1 site in United States.
Trial summary
Presently there is no apparatus, clinically available, for routine determination of cardiac output (CO) in children. The goal of this research is to develop new technology that will help determine CO in neonates. Read more about this study
- Who is it for?
- Ages Up to 1 month
- Conditions the study is for
- Neonatal Intensive Care
- What is being tested?
- COstatus cardiac output measurement with isotonic saline
- Type of treatment
- Medical device
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to May 2013
- Phase
- Observational
- 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 Up to 1 month
- All sexes
- No healthy volunteers
- Child
Study population: Patients from Neonatal Intensive Care Unit
Who may be able to join
- All neonatal patients cared for in our ICU with umbilical venous and arterial catheters simultaneously in place for their care, will be eligible.
Who cannot join
- Patients would be excluded if the family/guardian denied permission or if the attending physician felt the patient was not stable.
Trial locations and contacts
1 site in 1 country.
About this study
Presently there is no apparatus, clinically available, for routine determination of cardiac output (CO) in children. The goal of this research is to develop new technology that will help determine CO in neonates.
- Conditions
- Neonatal Intensive Care
- Being tested
- COstatus cardiac output measurement with isotonic saline
- Keywords
- Cardiac Output, Blood volumes, Neonates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COstatus cardiac output measurement with isotonic salineDevice
Isotonic saline, which is the indicator, is injected to obtain COstatus cardiac output measurements.
No other interventions are made for the purpose of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2012 (estimated)
- Study startMar 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Intensive CareStudies of the same condition, open and under way.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Transonic Systems Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Bonnie Marr, MD, Principal investigator, Crouse Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01610622
- Sponsor's protocol ID
- TSI-C-COSTATUS-4A-H
- Other IDs
- R44HL061994
- Acronym
- CH
- Status last verified
- May 2016
- First submitted
- 30 May 2012
- Last updated
- 27 May 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of Cardiac Output in Neonatal ICU Using an Ultrasound Dilution Technique
- ClinicalTrials.gov ID
- NCT01610622
- Acronym / sponsor ID
- CH / TSI-C-COSTATUS-4A-H
- Conditions
- Neonatal Intensive Care
- Keywords
- Cardiac Output, Blood volumes, Neonates
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Transonic Systems Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Mar 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 4 Jun 2012 (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.
Presently there is no apparatus, clinically available, for routine determination of cardiac output (CO) in children. The goal of this research is to develop new technology that will help determine CO in neonates.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients from Neonatal Intensive Care Unit
Key inclusion criteria (1 listed)
- All neonatal patients cared for in our ICU with umbilical venous and arterial catheters simultaneously in place for their care, will be eligible.
Key exclusion criteria (1 listed)
- Patients would be excluded if the family/guardian denied permission or if the attending physician felt the patient was not stable.
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 |
|---|---|---|
| COstatus cardiac output measurement with isotonic salineIsotonic saline, which is the indicator, is injected to obtain COstatus cardiac output measurements. No other interventions are made for the purpose of the study. | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2016.
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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.
Bonnie Marr, MD principal investigator
Crouse Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Intensive Care, run by Transonic Systems Inc. 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: finished, as of the sponsor's last update on 27 May 2016. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 27 May 2016; AzTrials last refreshed its copy on 7 Nov 2026.