Study by 2D-strain of the Ventricular Wall Motion During Postnatal Adaptation
NCT ID: NCT03654430
Last Updated: 2018-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
36 participants
INTERVENTIONAL
2018-04-03
2018-08-24
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Healthy Newborns
Echocardiography
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
Interventions
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Echocardiography
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
Eligibility Criteria
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Inclusion Criteria
* Aged between 2 and 5 day of life at the first echocardiography
* Social security affiliation
* Signature of the consent document by both parents
Exclusion Criteria
* Birth weight \< 2,5kg or \> 4,5kg
* Gestational Diabetes Mellitus during pregnancy
* Fetal heart disease
2 Days
5 Days
ALL
Yes
Sponsors
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TIMC-IMAG
OTHER
University Hospital, Grenoble
OTHER
Responsible Party
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Locations
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Johanne Auriau
Grenoble, , France
Countries
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Other Identifiers
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38RC18.014
Identifier Type: -
Identifier Source: org_study_id