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Completed

NCT Number: NCT03654430

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

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.

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Key information

Conditions

Age range

2 day–5 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johanne Auriau

Grenoble, 38043, France

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

echocardiography

Other

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

Primary outcomes

  1. Left ventricular Twist

    Time frame: 3 months

    Peak LV twist (°)

Secondary outcomes

  1. Left ventricular Rotation

    Time frame: 3 months

    Basal Rotation (°); Apical Rotation (°); Peak LV twist rate (°/s); Peak LV systolic torsion

  2. Untwist

    Time frame: 3 months

    Peak LV Untwist rate (°/sec)

  3. Left ventricular deformation

    Time frame: 3 months

    Basal and Apical Circumferential Strain (%); Basal and Apical Radial Strain (%)

  4. Comparison between Endocardial and Epicardial deformation

    Time frame: 3 months

    Inner and Outer Circumferential Strain (%)

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • TIMC-IMAG

Registry information

Official study title

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

Acronym: BABYSTRAIN

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 31, 2018
Registry last updated
Dec 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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