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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: Echocardiography

• Registration Number: NCT03654430
• Lead Sponsor: University Hospital, Grenoble

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

Study Timeline

• Study Start: 2018-04-03
• Study First Submitted: 2018-05-14
• Primary Completion: 2018-08-24
• Study Completion: 2018-08-24
• Study First Submitted QC: 2018-08-29
• Study First Posted: 2018-08-31
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-10
• Last Update Posted: 2018-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy Newborns	Echocardiography	-

Primary Outcome Measures

Name	Time	Method
Left ventricular Twist	3 months	Peak LV twist (°)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Johanne Auriau; 🇫🇷 Grenoble, France