Added Value of Supersonic Shear Imaging in the Diagnosis of White Matter Damage in Preterm Infants (BELUGA)
Primary Purpose
Preterm
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
diagnosis of white matter damage in preterm infants
Sponsored by
About this trial
This is an interventional prevention trial for Preterm focused on measuring preterm and term newborns, diagnosis of cerebral white matter damage, quantitative brain elasticity, Transfontanel ultrafast doppler
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;
Sites / Locations
- Hôpital Robert Debré
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
diagnosis of white matter damage
Arm Description
Added value of supersonic shear imaging in the diagnosis of white matter damage in preterm infants
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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.
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.
Full Information
NCT ID
NCT02042716
First Posted
July 26, 2013
Last Updated
April 16, 2019
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT02042716
Brief Title
Added Value of Supersonic Shear Imaging in the Diagnosis of White Matter Damage in Preterm Infants
Acronym
BELUGA
Official Title
Added Value of Supersonic Shear Imaging in the Diagnosis of White Matter Damage in Preterm Infants
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
February 2019 (Actual)
Study Completion Date
February 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm
Keywords
preterm and term newborns, diagnosis of cerebral white matter damage, quantitative brain elasticity, Transfontanel ultrafast doppler
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
128 (Actual)
8. Arms, Groups, and Interventions
Arm Title
diagnosis of white matter damage
Arm Type
Experimental
Arm Description
Added value of supersonic shear imaging in the diagnosis of white matter damage in preterm infants
Intervention Type
Other
Intervention Name(s)
diagnosis of white matter damage in preterm infants
Intervention Description
Added value of supersonic shear imaging in the diagnosis of white matter damage in preterm infants
Primary Outcome Measure Information:
Title
Sequences quantitative elastography and ultra-sensitive Doppler ultrasound performed on AixplorerTM (V2) data of brain MRI preterm infants.
Description
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
Time Frame
Up to on 40GA + /-1week fo preterm infants<32GA. For newborns at term:on day3+-1d
Secondary Outcome Measure Information:
Title
Correlation and comparison of measures elastography MRI to determine the prognosis of brain abnormalities detected by elastography
Description
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
Time Frame
For preterm infants <32GA:up to 40GA+/-1 week.For newborns at term :on day3+-1
Title
Quantitative cerebral perfusion values obtained by Doppler ultra-sensitive
Description
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.
Time Frame
up to 40GA + /-1week for preterm infants <32GA .For newborns at term :on day3+-1
Title
Cerebral perfusion values obtained by Doppler ultra-sensitive
Description
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.
Time Frame
on day21 + /-1d
10. Eligibility
Sex
All
Minimum Age & Unit of Time
24 Weeks
Maximum Age & Unit of Time
40 Weeks
Accepts Healthy Volunteers
No
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Biran Valerie, MP,PHD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Robert Debré
City
Paris
ZIP/Postal Code
75019
Country
France
12. IPD Sharing Statement
Learn more about this trial
Added Value of Supersonic Shear Imaging in the Diagnosis of White Matter Damage in Preterm Infants
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