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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03654430
Acronym
BABYSTRAIN
Enrollment
36
Registered
2018-08-31
Start date
2018-04-03
Completion date
2018-08-24
Last updated
2018-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Left ventricular Twist, 2D-speckle-tracking, Postnatal adaptation

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

Interventions

OTHEREchocardiography

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

Sponsors

TIMC-IMAG
CollaboratorOTHER
University Hospital, Grenoble
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Days to 5 Days
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Left ventricular Twist3 monthsPeak LV twist (°)

Secondary

MeasureTime frameDescription
Left ventricular Rotation3 monthsBasal Rotation (°); Apical Rotation (°); Peak LV twist rate (°/s); Peak LV systolic torsion
Untwist3 monthsPeak LV Untwist rate (°/sec)
Left ventricular deformation3 monthsBasal and Apical Circumferential Strain (%); Basal and Apical Radial Strain (%)
Comparison between Endocardial and Epicardial deformation3 monthsInner and Outer Circumferential Strain (%)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026