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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02042716
Acronym
BELUGA
Enrollment
128
Registered
2014-01-23
Start date
2013-12-31
Completion date
2019-02-28
Last updated
2019-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm

Keywords

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

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.

Interventions

OTHERdiagnosis of white matter damage in preterm infants

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

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
24 Weeks to 40 Weeks
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;

Design outcomes

Primary

MeasureTime frameDescription
Sequences quantitative elastography and ultra-sensitive Doppler ultrasound performed on AixplorerTM (V2) data of brain MRI preterm infants.Up to on 40GA + /-1week fo preterm infants<32GA. For newborns at term:on day3+-1dTo 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

MeasureTime frameDescription
Correlation and comparison of measures elastography MRI to determine the prognosis of brain abnormalities detected by elastographyFor preterm infants <32GA:up to 40GA+/-1 week.For newborns at term :on day3+-1Longitudinal 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
Quantitative cerebral perfusion values obtained by Doppler ultra-sensitiveup to 40GA + /-1week for preterm infants <32GA .For newborns at term :on day3+-1Quantitative 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.
Cerebral perfusion values obtained by Doppler ultra-sensitiveon day21 + /-1dCerebral 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026