NewbornVELOCITENCT03553134
Descriptive Study of Brain Velocity in Transcranial Doppler in Newborns Over 35 Weeks of Gestational Age in the Maternity Ward
An observational study of Newborn, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
There are significant variations in blood circulation at birth with the transition from fetal to permanent circulation. These variations are particularly impacted by the closure of the arterial canal within the first 48 hours of life. Read more about this study
- Who is it for?
- Ages Up to 6 hoursHealthy volunteers can take part
- Conditions the study is for
- Newborn
- What is being tested?
- transcranial doppler ultrasound scan and ultrasound scan centered on the arterial canal
- How many people
- 41 participants
- Where
- 1 siteFrance
- Study dates
- 19 Apr 2018to 25 Oct 2018
- 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 6 hours
- All sexes
- Healthy volunteers accepted
- Child
Study population: Newborns over 35 weeks of amenorrhoea
Who may be able to join
- Written consent of parent
- Newborns over 35 weeks of amenorrhoea hospitalized in the maternity ward
Who cannot join
- person not affiliated to a health insurance scheme
- Sepsis
- Ductal dependent heart disease
- Neurological impairment (anoxoischemic encephalopathy Sarnat>1, pH<7 and/or lactates>11, meningitis)
- Obstetrical trauma (instrumental delivery by forceps, vacuum cup or spatulas)
- Potentially lethal malformation
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- Anemia (hemoglobin<14g/dl)
- Polyglobulia (hemoglobin>22g/dl)
- Small for gestational age (weight<10th percentile)
- Large for gestational age (weight>97th percentile)
- Proven gestational diabetes (non-insulin-dependent and insulin-dependent)
- Maternal medical treatment (cardiac or anti-epileptic)
- Inadequate parent understanding
Trial locations and contacts
1 site in 1 country.
About this study
There are significant variations in blood circulation at birth with the transition from fetal to permanent circulation. These variations are particularly impacted by the closure of the arterial canal within the first 48 hours of life.
Blood circulation velocity values within the cerebral arteries have been well documented in newborns and infants a few days old. However, the initial values of these velocities and their variations during the first hours of life are not well known.
The objective of this study is to describe the evolution of brain circulation at birth in newborns over 35 weeks of gestational age and to investigate the effect of arterial canal closure on brain circulation.
- Conditions
- Newborn
- Being tested
- transcranial doppler ultrasound scan, ultrasound scan centered on the arterial canal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial doppler ultrasound scanDiagnostic test
Carried out at 4 different times: at birth, 6, 24 and 48 hours of life (duration: 10 minutes)
ultrasound scan centered on the arterial canalDiagnostic test
Carried out at 4 different times: at birth, 6, 24 and 48 hours of life (duration: 5 minutes)
What is being measured
The primary outcome is the main question the study is designed to answer.
Right and left average velocity of the cerebral artery
Measured: Change from birth to 48 hours of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study start19 Apr 2018
- Primary completion25 Oct 2018
- Study completion25 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NewbornStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03553134
- Sponsor's protocol ID
- LITZLER-RENAULT 2018 VELOCITE
- Acronym
- VELOCITE
- Status last verified
- Sep 2019
- First submitted
- 29 May 2018
- Last updated
- 4 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptive Study of Brain Velocity in Transcranial Doppler in Newborns Over 35 Weeks of Gestational Age in the Maternity Ward
- ClinicalTrials.gov ID
- NCT03553134
- Acronym / sponsor ID
- VELOCITE / LITZLER-RENAULT 2018 VELOCITE
- Conditions
- Newborn
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 19 Apr 2018 (actual)
- Primary completion
- 25 Oct 2018 (actual)
- Study completion
- 25 Oct 2018 (actual)
- First posted
- 12 Jun 2018 (actual)
- 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.
There are significant variations in blood circulation at birth with the transition from fetal to permanent circulation. These variations are particularly impacted by the closure of the arterial canal within the first 48 hours of life.
Blood circulation velocity values within the cerebral arteries have been well documented in newborns and infants a few days old. However, the initial values of these velocities and their variations during the first hours of life are not well known.
The objective of this study is to describe the evolution of brain circulation at birth in newborns over 35 weeks of gestational age and to investigate the effect of arterial canal closure on brain circulation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 6 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Newborns over 35 weeks of amenorrhoea
Key inclusion criteria (2 listed)
- Written consent of parent
- Newborns over 35 weeks of amenorrhoea hospitalized in the maternity ward
Key exclusion criteria (13 listed)
- person not affiliated to a health insurance scheme
- Sepsis
- Ductal dependent heart disease
- Neurological impairment (anoxoischemic encephalopathy Sarnat>1, pH<7 and/or lactates>11, meningitis)
- Obstetrical trauma (instrumental delivery by forceps, vacuum cup or spatulas)
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 |
|---|---|---|
| transcranial doppler ultrasound scanCarried out at 4 different times: at birth, 6, 24 and 48 hours of life (duration: 10 minutes) | Diagnostic test | – |
| ultrasound scan centered on the arterial canalCarried out at 4 different times: at birth, 6, 24 and 48 hours of life (duration: 5 minutes) | Diagnostic test | – |
Primary outcome
Right and left average velocity of the cerebral artery
Time frame: Change from birth to 48 hours of life
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 4 Sep 2019.
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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 Newborn, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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 2 inclusion and 13 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 4 Sep 2019. 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 France. 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?
Right and left average velocity of the cerebral artery (time frame: Change from birth to 48 hours of life). 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 4 Sep 2019.