Exchange TransfusionNCT00862485
MCA Doppler Studies in Neborns Following Exchange Transfusion
An observational study of Exchange Transfusion, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
The purpose of this study is to study MCA Doppler before and after exchange transfusion in newborns. Read more about this study
- Who is it for?
- Ages Up to 30 daysHealthy volunteers can take part
- Conditions the study is for
- Exchange Transfusion
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2009to Dec 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 30 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: newborns
Who may be able to join
- Newborns who need exchange transfusion by accepted criteria
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to study MCA Doppler before and after exchange transfusion in newborns.
- Conditions
- Exchange Transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| StudyGroup | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Doppler measurement
Doppler of middle cerebral artery
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exchange TransfusionStudies 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
- Observational model
- Case only
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, wamir, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00862485
- Sponsor's protocol ID
- 1910CTIL
- Status last verified
- Apr 2016
- First submitted
- 15 Mar 2009
- Last updated
- 6 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MCA Doppler Studies in Neborns Following Exchange Transfusion
- ClinicalTrials.gov ID
- NCT00862485
- Acronym / sponsor ID
- 1910CTIL
- Conditions
- Exchange Transfusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Dec 2013 (actual)
- First posted
- 17 Mar 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 study MCA Doppler before and after exchange transfusion in newborns.
Study design
- Observational model
- Case only
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| StudyGroup | – | – |
Who may qualify
- Ages
- Up to 30 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- newborns
Key inclusion criteria (1 listed)
- Newborns who need exchange transfusion by accepted criteria
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Doppler measurement
Time frame: one year
Doppler of middle cerebral artery
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 6 Apr 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Exchange Transfusion, run by Rambam Health Care Campus at 1 site in Israel.
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 0 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 6 Apr 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 Israel. 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.
What does the primary outcome measure?
Doppler measurement (time frame: one 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 6 Apr 2016.