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

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.

Study Overview

• Status: Completed
• Conditions: Preterm
• Intervention / Treatment: Other: diagnosis of white matter damage in preterm infants

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 Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75019
    • Hopital Robert Debre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 9 months (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: diagnosis of white matter damage; 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; Added value of supersonic shear imaging in the diagnosis of white matter damage in preterm infants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation and comparison of measures elastography MRI to determine the prognosis of brain abnormalities detected by elastography	Longitudinal comparison of measures of quantitative elastography in the supratentorial white matter, corpus callosum, gray matter (basal ganglia) and white matter infratentorial (cerebellar hemispheres) during development in preterm infants <32 weeks and compared the values obtained in the newborn term. For preterm infants <32GA:on day0-day1, day3 + /-1d, day8, day21 + /-1d; 40GA + /-1week.For newborns at term :on day3+-1	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	Quantitative cerebral perfusion values obtained by Doppler ultra-sensitive (with standard setting speeds) in premature infants with and without white matter lesions in the frontal white matter and basal ganglia (temporal curve of blood flow in the region interest with defined and standardized measurement of peak systolic and diastolic values: pulsatility index.	up to 40GA + /-1week for preterm infants <32GA .For newborns at term :on day3+-1
Cerebral perfusion values obtained by Doppler ultra-sensitive	Cerebral perfusion values obtained by ultra-sensitive Doppler in premature infants with abnormal EEG characterized (positive rolandic spikes> 2 min, convulsions ...) during the first 21 days of life.	on day21 + /-1d

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Biran Valerie, MP,PHD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (ACTUAL): February 1, 2019
• Study Completion (ACTUAL): February 1, 2019

Study Registration Dates

• First Submitted: July 26, 2013
• First Submitted That Met QC Criteria: January 22, 2014
• First Posted (ESTIMATE): January 23, 2014

Study Record Updates

• Last Update Posted (ACTUAL): April 17, 2019
• Last Update Submitted That Met QC Criteria: April 16, 2019
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: preterm and term newborns; diagnosis of cerebral white matter damage; quantitative brain elasticity; Transfontanel ultrafast doppler
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: P120601; ID RCB : 2012-A01530-43 (OTHER: ID RCB)