Hôpital Robert Debré
Paris, 75019, France
NCT Number: NCT02042716
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.
Looking for future studies?
Notify Me24 week–40 week
All sexes
Interventional
Not applicable
Paris, 75019, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Added value of supersonic shear imaging in the diagnosis of white matter damage in 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
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
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.
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.
Assistance Publique - Hôpitaux de Paris
Other
Acronym: BELUGA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07727720
Female Urogenital Diseases and Pregnancy Complications, Obstetric Labor Complications
Istanbul, Beykoz, Turkey (Türkiye)
View Trial DetailsNCT07068581
Female Urogenital Diseases and Pregnancy Complications, Obstetric Labor Complications
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT06937580
Female Urogenital Diseases and Pregnancy Complications, Kangaroo Mother Care
Accra, Greater Accra Region, Ghana
View Trial DetailsNCT06204146
Female Urogenital Diseases and Pregnancy Complications, Obstetric Labor Complications
Batman, Merkez, Turkey (Türkiye)
View Trial Details