Johanne Auriau
Grenoble, 38043, France
NCT Number: NCT03654430
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.
Looking for future studies?
Notify Me2 day–5 day
All sexes
Interventional
Not applicable
Grenoble, 38043, France
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 3 months
Peak LV twist (°)
Time frame: 3 months
Basal Rotation (°); Apical Rotation (°); Peak LV twist rate (°/s); Peak LV systolic torsion
Time frame: 3 months
Peak LV Untwist rate (°/sec)
Time frame: 3 months
Basal and Apical Circumferential Strain (%); Basal and Apical Radial Strain (%)
Time frame: 3 months
Inner and Outer Circumferential Strain (%)
University Hospital, Grenoble
Other
Longitudinal Study by 2D-speckle-tracking Echocardiography of the Ventricular Wall Motion During Postnatal Adaptation
Acronym: BABYSTRAIN
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06068257
Breast Cancer, Breast Diseases
Orlando, Florida, United States
View Trial DetailsNCT06702423
Healthy
London, United Kingdom
View Trial DetailsNCT07223164
Healthy
Irvine, California, United States
View Trial DetailsNCT05595902
Healthy
Kadıköy, Istanbul, Turkey (Türkiye)
View Trial Details