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Clinical Trials/NCT03654430
NCT03654430
Completed
Not Applicable

Longitudinal Study by 2D-speckle-tracking Echocardiography of the Ventricular Wall Motion During Postnatal Adaptation

University Hospital, Grenoble1 site in 1 country36 target enrollmentApril 3, 2018
ConditionsHealthy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
University Hospital, Grenoble
Enrollment
36
Locations
1
Primary Endpoint
Left ventricular Twist
Status
Completed
Last Updated
7 years ago

Overview

Brief 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

Registry
clinicaltrials.gov
Start Date
April 3, 2018
End Date
August 24, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
University Hospital, Grenoble
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • Birth before 37 weeks gestation
  • Birth weight \< 2,5kg or \> 4,5kg
  • Gestational Diabetes Mellitus during pregnancy
  • Fetal heart disease

Outcomes

Primary Outcomes

Left ventricular Twist

Time Frame: 3 months

Peak LV twist (°)

Secondary Outcomes

  • Left ventricular Rotation(3 months)
  • Left ventricular deformation(3 months)
  • Untwist(3 months)
  • Comparison between Endocardial and Epicardial deformation(3 months)

Study Sites (1)

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