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

Healthy Clinical Trial

— BABYSTRAIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03654430
• Other study ID #: 38RC18.014
• Status: Completed
• Phase: N/A
• Start date: April 3, 2018
• Est. completion date: August 24, 2018

Study information

• Verified date: December 2018
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 24, 2018
• Est. primary completion date: August 24, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 5 Days

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
France	Johanne Auriau	Grenoble

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Grenoble	TIMC-IMAG

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricular Twist	Peak LV twist (°)	3 months
Secondary	Left ventricular Rotation	Basal Rotation (°); Apical Rotation (°); Peak LV twist rate (°/s); Peak LV systolic torsion	3 months
Secondary	Untwist	Peak LV Untwist rate (°/sec)	3 months
Secondary	Left ventricular deformation	Basal and Apical Circumferential Strain (%); Basal and Apical Radial Strain (%)	3 months
Secondary	Comparison between Endocardial and Epicardial deformation	Inner and Outer Circumferential Strain (%)	3 months