HealthyBABYSTRAINNCT03654430
Study by 2D-strain of the Ventricular Wall Motion During Postnatal Adaptation
A study testing Echocardiography in people with Healthy, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The left ventricular torsion during systole and diastole is a normal dynamic mechanism which participates in the ejection and the filling of the left ventricle. Postnatal hemodynamic modifications are major and probably affect this mechanism. Read more about this study
- Who is it for?
- Ages 2 to 5 daysHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Echocardiography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 3 Apr 2018to 24 Aug 2018
- 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 2 to 5 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Newborn hospitalized in the Grenoble University Hospital Maternity Unit
- Aged between 2 and 5 day of life at the first echocardiography
- Social security affiliation
- Signature of the consent document by both parents
Who cannot join
- Birth before 37 weeks gestation
- Birth weight < 2,5kg or > 4,5kg
- Gestational Diabetes Mellitus during pregnancy
- Fetal heart disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Longitudinal Study by 2D-speckle-tracking Echocardiography of the Ventricular Wall Motion During Postnatal Adaptation
The left ventricular torsion during systole and diastole is a normal dynamic mechanism which participates in the ejection and the filling of the left ventricle. Postnatal hemodynamic modifications are major and probably affect this mechanism. The aim of this study is to compare the left ventricular twist in healthy newborns, between their first days of life and their third month of life, using the 2D-speckle tracking echocardiography.
Read the detailed description
The left ventricular torsion during systole and diastole is a normal dynamic mechanism which participates in the ejection and the filling of the left ventricle. Postnatal hemodynamic modifications are major and probably affect this mechanism.
The main objective is to compare the left ventricular twist mechanism in healthy newborns, at birth and at their third month of life, using the peak LV twist as primary endpoint. Secondarily, we compare other LV rotation and deformation parameters during the same period: peak LV torsion, peak LV twist rate, peak LV untwist rate, circumferential strain and radial strain. Finally, we compare the endo- and epicardial LV deformation, using the inner and outer circumferential strain as endpoints.
This is a longitudinal, prospective and monocentric study in the Grenoble-Alpes University Hospital between April 2018 and September 2018.
The number of required subjects is 30 with a statistical power of 80% and a p-value of 0,05
- Conditions
- Healthy
- Being tested
- Echocardiography
- Keywords
- Left ventricular Twist, 2D-speckle-tracking, Postnatal adaptation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyOther
Two echocardiographies will be performed in healthy newborns: The first between day 2 and day 5 of life, the second between day 60 and day 90 of life
| Study group | Role | What they receive |
|---|---|---|
| Healthy Newborns | Other | Not described Receives: Other: Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular Twist
Peak LV twist (°)
Measured: 3 months
Secondary outcomes (4)
Left ventricular Rotation
Basal Rotation (°); Apical Rotation (°); Peak LV twist rate (°/s); Peak LV systolic torsion
Measured: 3 months
Untwist
Peak LV Untwist rate (°/sec)
Measured: 3 months
Left ventricular deformation
Basal and Apical Circumferential Strain (%); Basal and Apical Radial Strain (%)
Measured: 3 months
Comparison between Endocardial and Epicardial deformation
Inner and Outer Circumferential Strain (%)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start3 Apr 2018
- Primary completion24 Aug 2018
- Study completion24 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- TIMC-IMAG
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03654430
- Sponsor's protocol ID
- 38RC18.014
- Acronym
- BABYSTRAIN
- Status last verified
- Dec 2018
- First submitted
- 14 May 2018
- Last updated
- 12 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Study by 2D-speckle-tracking Echocardiography of the Ventricular Wall Motion During Postnatal Adaptation
- ClinicalTrials.gov ID
- NCT03654430
- Acronym / sponsor ID
- BABYSTRAIN / 38RC18.014
- Conditions
- Healthy
- Keywords
- Left ventricular Twist, 2D-speckle-tracking, Postnatal adaptation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- TIMC-IMAG
- Study start
- 3 Apr 2018 (actual)
- Primary completion
- 24 Aug 2018 (actual)
- Study completion
- 24 Aug 2018 (actual)
- First posted
- 31 Aug 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.
The left ventricular torsion during systole and diastole is a normal dynamic mechanism which participates in the ejection and the filling of the left ventricle. Postnatal hemodynamic modifications are major and probably affect this mechanism. The aim of this study is to compare the left ventricular twist in healthy newborns, between their first days of life and their third month of life, using the 2D-speckle tracking echocardiography.
Detailed description
The left ventricular torsion during systole and diastole is a normal dynamic mechanism which participates in the ejection and the filling of the left ventricle. Postnatal hemodynamic modifications are major and probably affect this mechanism.
The main objective is to compare the left ventricular twist mechanism in healthy newborns, at birth and at their third month of life, using the peak LV twist as primary endpoint. Secondarily, we compare other LV rotation and deformation parameters during the same period: peak LV torsion, peak LV twist rate, peak LV untwist rate, circumferential strain and radial strain. Finally, we compare the endo- and epicardial LV deformation, using the inner and outer circumferential strain as endpoints.
This is a longitudinal, prospective and monocentric study in the Grenoble-Alpes University Hospital between April 2018 and September 2018.
The number of required subjects is 30 with a statistical power of 80% and a p-value of 0,05
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Newborns | Other | Other: Echocardiography |
Who may qualify
- Ages
- 2 to 5 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Newborn hospitalized in the Grenoble University Hospital Maternity Unit
- Aged between 2 and 5 day of life at the first echocardiography
- Social security affiliation
- Signature of the consent document by both parents
Key exclusion criteria (4 listed)
- Birth before 37 weeks gestation
- Birth weight < 2,5kg or > 4,5kg
- Gestational Diabetes Mellitus during pregnancy
- Fetal heart disease
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 |
|---|---|---|
| EchocardiographyTwo echocardiographies will be performed in healthy newborns: The first between day 2 and day 5 of life, the second between day 60 and day 90 of life | Other | Healthy Newborns |
Primary outcome
Left ventricular Twist
Time frame: 3 months
Peak LV twist (°)
4 secondary outcomes
Left ventricular Rotation
Time frame: 3 months
Untwist
Time frame: 3 months
Left ventricular deformation
Time frame: 3 months
Comparison between Endocardial and Epicardial deformation
Time frame: 3 months
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 12 Dec 2018.
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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?
A study testing Echocardiography in people with Healthy, run by University Hospital, Grenoble 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 4 inclusion and 4 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 12 Dec 2018. 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?
Left ventricular Twist (time frame: 3 months). 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 12 Dec 2018.