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Clinical Trials/NCT02042716
NCT02042716CompletedNot Applicable

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

Assistance Publique - Hôpitaux de Paris1 site in 1 country128 target enrollmentStarted: December 1, 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
128
Locations
1
Primary Endpoint
Sequences quantitative elastography and ultra-sensitive Doppler ultrasound performed on AixplorerTM (V2) data of brain MRI preterm infants.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
24 Weeks to 40 Weeks (Child)
Sex
All
Accepts Healthy Volunteers
No

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;

Arms & Interventions

diagnosis of white matter damage

Experimental

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

Intervention: diagnosis of white matter damage in preterm infants (Other)

Outcomes

Primary Outcomes

Sequences quantitative elastography and ultra-sensitive Doppler ultrasound performed on AixplorerTM (V2) data of brain MRI preterm infants.

Time Frame: Up to on 40GA + /-1week fo preterm infants<32GA. For newborns at term:on day3+-1d

To describe the feasibility and reproducibility of quantitative elasticity mapping in preterm infants and to correlate to gestational age * For preterm infants \<32GA: Quantitative elasticity mapping will be repeated at different stages of postnatal development of preterm infants: on day0-day1, day3 + /-1d, day8, day21 + /-1d; 40GA + /-1week. * For newborns at term (39-40GA +6 d) : Quantitative elasticity mapping will be performed on day3+-1

Secondary Outcomes

  • Quantitative cerebral perfusion values obtained by Doppler ultra-sensitive(up to 40GA + /-1week for preterm infants <32GA .For newborns at term :on day3+-1)
  • Cerebral perfusion values obtained by Doppler ultra-sensitive(on day21 + /-1d)
  • Correlation and comparison of measures elastography MRI to determine the prognosis of brain abnormalities detected by elastography(For preterm infants <32GA:up to 40GA+/-1 week.For newborns at term :on day3+-1)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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