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

NCT02042716 | Completed

• 2 other identifiers: P120601ID RCB : 2012-A01530-43
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm

Keywords

preterm and term newborns; diagnosis of cerebral white matter damage; quantitative brain elasticity; Transfontanel ultrafast doppler

Outcome Measures

Primary Outcomes (1)

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

  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

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

Secondary Outcomes (3)

• 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

• 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

Study Arms (1)

diagnosis of white matter damage

EXPERIMENTAL

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

Other: diagnosis of white matter damage in preterm infants

Interventions

diagnosis of white matter damage in preterm infants OTHER

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

diagnosis of white matter damage

Eligibility Criteria

• Age: 24 Weeks - 40 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Malformation known pathology;
• Known chromosomal abnormality;

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Robert Debré

Paris, 75019, France

Location

Related Publications (1)

• 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.

  PMID: 38782968 DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Biran Valerie, MP,PHD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 26, 2013
• First Posted: January 23, 2014
• Study Start: December 1, 2013
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: April 17, 2019

Record last verified: 2018-02

Locations

FR (1)