PretermBELUGANCT02042716
Added Value of Supersonic Shear Imaging in the Diagnosis of White Matter Damage in Preterm Infants
A study testing diagnosis of white matter damage in preterm infants in people with Preterm, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 24 to 40 weeks
- Conditions the study is for
- Preterm
- What is being tested?
- diagnosis of white matter damage in preterm infants
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2013to Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 40 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Malformation known pathology;
- Known chromosomal abnormality;
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
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.
Read the 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.
- Conditions
- Preterm
- Being tested
- diagnosis of white matter damage in preterm infants
- Keywords
- preterm and term newborns, diagnosis of cerebral white matter damage, quantitative brain elasticity, Transfontanel ultrafast doppler
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnosis of white matter damage in preterm infantsOther
Added value of supersonic shear imaging in the diagnosis of white matter damage in preterm infants
| Study group | Role | What they receive |
|---|---|---|
| diagnosis of white matter damage | Experimental | Added value of supersonic shear imaging in the diagnosis of white matter damage in preterm infants Receives: Other: diagnosis of white matter damage in preterm infants |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to on 40GA + /-1week fo preterm infants<32GA. For newborns at term:on day3+-1d
Secondary outcomes (3)
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
Measured: 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.
Measured: 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.
Measured: on day21 + /-1d
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionFeb 2019
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PretermStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Biran Valerie, MP,PHD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02042716
- Sponsor's protocol ID
- P120601
- Other IDs
- ID RCB : 2012-A01530-43
- Acronym
- BELUGA
- Status last verified
- Feb 2018
- First submitted
- 26 Jul 2013
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Faure F, Alison M, Francavilla M, Boizeau P, Guilmin Crepon S, Lim C, Planchette G, Prigent M, Frerot A, Tanter M, Demene C, Baud O, Biran V. Transfontanellar shear wave elastography of the neonatal brain for quantitative evaluation of white matter damage. Sci Rep. 2024 May 23;14(1):11827. doi: 10.1038/s41598-024-60968-w.
PubMed 38782968
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Added Value of Supersonic Shear Imaging in the Diagnosis of White Matter Damage in Preterm Infants
- ClinicalTrials.gov ID
- NCT02042716
- Acronym / sponsor ID
- BELUGA / P120601
- Conditions
- Preterm
- Keywords
- preterm and term newborns, diagnosis of cerebral white matter damage, quantitative brain elasticity, Transfontanel ultrafast doppler
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Feb 2019 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 23 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| diagnosis of white matter damage | Experimental | Other: diagnosis of white matter damage in preterm infantsAdded value of supersonic shear imaging in the diagnosis of white matter damage in preterm infants |
Who may qualify
- Ages
- 24 to 40 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Malformation known pathology;
- Known chromosomal abnormality;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diagnosis of white matter damage in preterm infantsAdded value of supersonic shear imaging in the diagnosis of white matter damage in preterm infants | Other | diagnosis of white matter damage |
Primary outcome
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
3 secondary outcomes
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
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
Cerebral perfusion values obtained by Doppler ultra-sensitive
Time frame: on day21 + /-1d
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Derived from this study: PubMed 38782968Faure F, Alison M, Francavilla M, Boizeau P, Guilmin Crepon S, Lim C, Planchette G, Prigent M, Frerot A, Tanter M, Demene C, Baud O, Biran V. Transfontanellar shear wave elastography of the neonatal brain for quantitative evaluation of white matter damage. Sci Rep. 2024 May 23;14(1):11827. doi: 10.1038/s41598-024-60968-w.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Biran Valerie, MP,PHD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diagnosis of white matter damage in preterm infants in people with Preterm, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02042716, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.