Added Value of Supersonic Shear Imaging in the Diagnosis of White Matter Damage in Preterm Infants

NCT ID: NCT02042716

Last Updated: 2019-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2019-02-28

Brief Summary

Preterm birth and perinatal events related can interrupt microscopic maturation of the developing white matter leading to diffuse injury and subsequent neurocognitive impairments. Brain maturation can be studied using diffusion tensor imaging but is difficult to assess early after birth, repeatedly and at the bedside. Supersonic Shear wave Imaging (SSI) could be of interest in this clinical setting. This technique, already investigated in adults (breast, thyroid or liver fibrosis staging), has not been yet evaluated in neonates.

Objective:

To describe the feasibility and reproducibility of quantitative elasticity mapping in preterm infants and to correlate to gestational age.

Methods:

SSI is a quantitative stiffness imaging technique based on the combination of a remote palpation induced into tissues by the radiation force a focused ultrasonic beam and an ultrafast ultrasound imaging sequence. Such ultrafast frame rates permit to track in real time the displacements induced by the propagation of the resulting shear waves. For each pixel, the shear wave speed can be estimated locally and enables quantitative mapping of the local shear elasticity (characterizing the stiffness in kPa). In this study, we will use a new generation of ultrafast ultrasound scanners (Aixplorer®, Supersonic Imagine, Aix en Provence, France) with a linear L10-2 probe (256 elements, 6 MHz) in neonates born between 25 and 40 weeks' gestation (n=100). Three separate acquisitions will be obtained for each area of interest both on right and left sides and stiffness was measured using a unique ROI of 2.5 cm².

Detailed Description

White matter damage occurs in 20% of preterm infants in industrialized countries. These lesions are difficult to evaluate by standard ultrasound. The quantitative elastography is a new medical imaging technique and potentially a diagnostic tool in brain lesions in preterm infants. Shear wave Imaging (SSI) could be of interest in this clinical setting. This technique, already investigated in adults (breast, thyroid or liver fibrosis staging), has not been yet evaluated in neonates.

Conditions

Preterm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

diagnosis of white matter damage

Added value of supersonic shear imaging in the diagnosis of white matter damage in preterm infants

Group Type: EXPERIMENTAL

diagnosis of white matter damage in preterm infants

Intervention Type: OTHER

Added value of supersonic shear imaging in the diagnosis of white matter damage in preterm infants

Interventions

diagnosis of white matter damage in preterm infants

Added value of supersonic shear imaging in the diagnosis of white matter damage in preterm infants

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• gestational age between 24 +0 and 31 +6 j GA) and 39 +0 and 40 +6 d (control group)
• Inborn or Outborn
• Informed consent of the holders of the exercise of parental authority
• recipient of a social security system (excluding AME) Child

Exclusion Criteria

• Malformation known pathology;
• Known chromosomal abnormality;

• Minimum Eligible Age: 24 Weeks
• Maximum Eligible Age: 40 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Biran Valerie, MP,PHD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Hôpital Robert Debré

Paris, , France

Countries

France

References

Faure F, Alison M, Francavilla M, Boizeau P, Guilmin Crepon S, Lim C, Planchette G, Prigent M, Frerot A, Tanter M, Demene C, Baud O, Biran V. Transfontanellar shear wave elastography of the neonatal brain for quantitative evaluation of white matter damage. Sci Rep. 2024 May 23;14(1):11827. doi: 10.1038/s41598-024-60968-w.

Reference Type: DERIVED

PMID: 38782968 (View on PubMed)

Other Identifiers

ID RCB : 2012-A01530-43

Identifier Type: OTHER

Identifier Source: secondary_id

P120601

Identifier Type: -

Identifier Source: org_study_id