Trials / Completed
CompletedNCT03654430
Study by 2D-strain of the Ventricular Wall Motion During Postnatal Adaptation
Longitudinal Study by 2D-speckle-tracking Echocardiography of the Ventricular Wall Motion During Postnatal Adaptation
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- University Hospital, Grenoble · Academic / Other
- Sex
- All
- Age
- 2 Days – 5 Days
- Healthy volunteers
- Accepted
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. 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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | 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 |
Timeline
- Start date
- 2018-04-03
- Primary completion
- 2018-08-24
- Completion
- 2018-08-24
- First posted
- 2018-08-31
- Last updated
- 2018-12-12
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT03654430. Inclusion in this directory is not an endorsement.