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

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ClinicalTrials.gov Identifier: NCT02042716
Recruitment Status : Completed
First Posted : January 23, 2014
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


Condition or disease Intervention/treatment Phase
Preterm Other: diagnosis of white matter damage in preterm infants Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Added Value of Supersonic Shear Imaging in the Diagnosis of White Matter Damage in Preterm Infants
Study Start Date : December 2013
Actual Primary Completion Date : February 2019
Actual Study Completion Date : February 2019

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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




Primary Outcome Measures :
  1. Sequences quantitative elastography and ultra-sensitive Doppler ultrasound performed on AixplorerTM (V2) data of brain MRI preterm infants. [ Time Frame: Up to on 40GA + /-1week fo preterm infants<32GA. For newborns at term:on day3+-1d ]

    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 :
  1. Correlation and comparison of measures elastography MRI to determine the prognosis of brain abnormalities detected by elastography [ Time Frame: For preterm infants <32GA:up to 40GA+/-1 week.For newborns at term :on day3+-1 ]

    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


  2. Quantitative cerebral perfusion values obtained by Doppler ultra-sensitive [ Time Frame: up to 40GA + /-1week for preterm infants <32GA .For newborns at term :on day3+-1 ]
    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.

  3. Cerebral perfusion values obtained by Doppler ultra-sensitive [ Time Frame: on day21 + /-1d ]
    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.



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Ages Eligible for Study:   24 Weeks to 40 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02042716


Locations
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France
Hôpital Robert Debré
Paris, France, 75019
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Biran Valerie, MP,PHD Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02042716     History of Changes
Other Study ID Numbers: P120601
ID RCB : 2012-A01530-43 ( Other Identifier: ID RCB )
First Posted: January 23, 2014    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: February 2018

Keywords provided by Assistance Publique - Hôpitaux de Paris:
preterm and term newborns
diagnosis of cerebral white matter damage
quantitative brain elasticity
Transfontanel ultrafast doppler

Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications