Clinical trial NCT02042716: Added Value of Supersonic Shear Imaging in the Diagnosis of White Matter Damage in Preterm Infants
Official title: Added Value of Supersonic Shear Imaging in the Diagnosis of White Matter Damage in Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm
Keywords: preterm and term newborns
diagnosis of cerebral white matter damage
quantitative brain elasticity
Transfontanel ultrafast doppler
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2014-01-23
Enrollment: 128
Sex: ALL
Minimum age (years): 24
Maximum age (years): 40
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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;

Primary outcomes:
measure: Sequences quantitative elastography and ultra-sensitive Doppler ultrasound performed on AixplorerTM (V2) data of brain MRI preterm infants.
timeFrame: Up to on 40GA + /-1week fo preterm infants<32GA. For newborns at term:on day3+-1d
Secondary outcomes:
measure: Correlation and comparison of measures elastography MRI to determine the prognosis of brain abnormalities detected by elastography
timeFrame: For preterm infants <32GA:up to 40GA+/-1 week.For newborns at term :on day3+-1
measure: Quantitative cerebral perfusion values obtained by Doppler ultra-sensitive
timeFrame: up to 40GA + /-1week for preterm infants <32GA .For newborns at term :on day3+-1
measure: Cerebral perfusion values obtained by Doppler ultra-sensitive
timeFrame: on day21 + /-1d
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Robert Debré
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Biran Valerie, MP,PHD
role: PRINCIPAL_INVESTIGATOR
References: