NCT03654430

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 3, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 14, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 31, 2018

Completed
Last Updated

December 12, 2018

Status Verified

December 1, 2018

Enrollment Period

5 months

First QC Date

May 14, 2018

Last Update Submit

December 10, 2018

Conditions

Healthy

Keywords

Left ventricular Twist2D-speckle-trackingPostnatal adaptation

Outcome Measures

Primary Outcomes (1)

  • Left ventricular Twist

    Peak LV twist (°)

    3 months

Secondary Outcomes (4)

  • Left ventricular Rotation

    3 months

  • Untwist

    3 months

  • Left ventricular deformation

    3 months

  • Comparison between Endocardial and Epicardial deformation

    3 months

Study Arms (1)

Healthy Newborns

OTHER
Other: Echocardiography

Interventions

EchocardiographyOTHER

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

Healthy Newborns

Eligibility Criteria

Age2 Days - 5 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Birth before 37 weeks gestation
  • Birth weight \< 2,5kg or \> 4,5kg
  • Gestational Diabetes Mellitus during pregnancy
  • Fetal heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johanne Auriau

Grenoble, 38043, France

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2018

First Posted

August 31, 2018

Study Start

April 3, 2018

Primary Completion

August 24, 2018

Study Completion

August 24, 2018

Last Updated

December 12, 2018

Record last verified: 2018-12

Locations

FR(1)