Study by 2D-strain of the Ventricular Wall Motion During Postnatal Adaptation

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Healthy

Intervention / Treatment
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* Other: Echocardiography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Days
Maximum Age: 5 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Healthy Newborns<br> | Other: Echocardiography<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular Twist | Peak LV twist (°) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular Rotation | Basal Rotation (°); Apical Rotation (°); Peak LV twist rate (°/s); Peak LV systolic torsion | 3 months | 
| Untwist | Peak LV Untwist rate (°/sec) | 3 months | 
| Left ventricular deformation | Basal and Apical Circumferential Strain (%); Basal and Apical Radial Strain (%) | 3 months | 
| Comparison between Endocardial and Epicardial deformation | Inner and Outer Circumferential Strain (%) | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Left ventricular Twist, 2D-speckle-tracking, Postnatal adaptation