Prospective Study of the Feasibility of Brain Connectivity Imaging by Functional Ultrasound Imaging (fUS) in Newborn Infant

NCT06940713 | Recruiting

• 2 other identifiers: C22-392024-A00963-44
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

Neurodevelopmental disorders (NDD) affect how the brain develops and can lead to lifelong difficulties with movement, learning, behavior, and thinking. Every year, around one million newborns in Europe are affected by these conditions. Some babies are at higher risk of NDD due to factors such as being born extremely premature, having poor growth in the womb, experiencing a lack of oxygen at birth, or having a family history of severe NDD. However, predicting which babies will develop these disorders is currently very challenging because there are no reliable early indicators (biomarkers) to detect them. The CONEXUS study is testing a new type of brain imaging technology called functional ultrasound imaging (fUS) to see if it can help assess brain function in newborns at high risk of NDD. This technique measures brain activity by detecting small changes in blood flow, similar to an ultrasound scan but using advanced imaging technology. Researchers believe this method, known as fC-fUS imaging, could help identify early signs of neurodevelopmental disorders. Preliminary studies have shown that fUS imaging can detect brain activity changes in newborns, such as differences between sleep states or during epileptic seizures. The CONEXUS study will expand on this by improving the imaging technology and testing it in a larger group of newborns, including those born prematurely, those with restricted growth, those who needed cooling treatment after birth due to lack of oxygen, and those at risk for autism spectrum disorder (ASD). The study is being conducted in multiple hospitals in France over five years, involving newborn intensive care, pediatrics, and child psychiatry teams. It is a feasibility study, meaning researchers aim to test whether this imaging technique is practical and effective for use in newborns. Babies will have short, painless fUS scans that focus on brain regions involved in movement, hearing, vision, and attention. Ultimately, the goal of CONEXUS is to demonstrate that fC-fUS imaging can help doctors understand early brain development and identify signs of neurodevelopmental disorders before symptoms appear. If successful, this technique could improve early diagnosis, allowing doctors to start treatment sooner and improve long-term outcomes for affected children. This research has the potential to transform neonatal care by providing a new tool for detecting and monitoring brain function in newborns.

Conditions

Neonates and Preterm Infants; Neonates or Premature Babies

Keywords

ultrasound imaging; functional ultrasound; neonatal intensive care imaging; prematurity; preterm; anoxo-ischemic encephalopathy; intrauterine growth restriction; functional connectivity; neonatology; neurodevelopment

Outcome Measures

Primary Outcomes (1)

• Feasibility of acquiring quantitative brain functional connectivity assessment using fUS data in 4 groups (G1 to G4) of newborns at high risk of neurodevelopmental disorder and a control group of term newborns.

  Each fUS acquisition, for each patient, each acquisition time point, each imaging plane, consists of a succession of fUS images recorded over a duration ranging from 5 to 10 minutes. The acquisition will be considered successful if at least 50% of the fUS images do not show motion artifacts (criterion used in our preliminary studies) (validity criterion) and if vascular structures are visible at a depth \>50% of the maximum depth (sensitivity criterion). If these two criteria are met, we can then average the fUS signal over the functional areas and calculate a correlation matrix.

  up to 16 weeks

Secondary Outcomes (4)

• Feasibility of longitudinal quantification of fUS connectivity of preterm (from birth to equivalent term age) and term newborns in different connectivity networks

  up to 16 weeks

• Potential correlation between fUS connectivity assessment and neuropsychological assessment at 2 years within the groups of newborns at high risk of neurodevelopmental disorder

  2 years

• Feasibility of acquisition of 3D vascular atlases specific to fUS imaging in order to document the evolution of cerebrovascular structures in newborns at high risk of neurodevelopmental disorder and term newborns

  up to 16 weeks

• Quantify potential correlates between fUS and EEG data thanks to the simultaneous fUS-EEG clinical recordings in newborns at high risk of neurodevelopmental disorder and term newborns.

  up to 16 weeks

Study Arms (1)

Feasibility of brain connectivity imaging by functional ultrasound imaging (fUS) in newborn infant

EXPERIMENTAL

Device: Imaging Time

Interventions

Imaging Time DEVICE

fUS: transfontanellar functional ultrasound imaging, performed using the CONEXUS system. fUS-EEG: transfontanellar functional ultrasound imaging, performed using the CONEXUS system, performed simultaneously with an EEG examination. The fUS examinations consist of recording brain activity for a few minutes in one of the imaging planes (Posterior Coronal, Median Coronal, Frontal Coronal, Right Para-sagittal, Right/Left Para-sagittal, 3-plane Antero-posterior Coronal) including structures involved in brain functional connectivity networks (somatosensory, auditory, visual, salience). These fUS examinations are conducted to perform longitudinal follow-up of patients in the 5 different groups.

Also known as: functional ultrasound imaging (fUS), fUS, functional ultrasound imaging combined with EEG (fUS-EEG), fUS-EEG, CONEXUS imaging

Feasibility of brain connectivity imaging by functional ultrasound imaging (fUS) in newborn infant

Eligibility Criteria

• Age: Up to 5 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \. For group G1 (Premature babies):
• Gestational children:
• a. Between 23 WA+5 days and 27 WA +6 days (extremely preterm) (G1) or
• b. Between 28 WA+0 days and 31 WA+6 days (very preterm) (G1)
• \. For the G2 group (AIE):
• Children of gestational age\> 36 WA + 0 days
• with neonatal anoxo-ischemic encephalopathy
• treated with controlled therapeutic hypothermia (group G2)
• \. For the G3 Group (IUGR): Gestational age between 32 WA+0 days and 40 WA+6 days and with IUGR intrauterine growth restriction: birth weight \< 10 p and/or head circumference \< 10 percentile (G3 group);
• \. For the G4 group :
• Siblings with at least one child with signs of autism spectrum disorder
• less than 6 months of age at baseline (G4 group)
• \. For the G5 group (control):
• Children of gestational age between 39 WA and 40 WA + 6 days
• without pathology during pregnancy (no vasculoplacental pathology, no threat of premature delivery, no maternal corticosteroid therapy, no consumption of toxic substances)

You may not qualify if:

• Person subject to a judicial safeguard measure (guardianship, curatorship or safeguard of justice)
• Known malformative pathology;
• Known chromosomal abnormality;
• Known allergy to silicone

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (1)

Hôpital Robert Debré

Paris, 75019, France

RECRUITING

MeSH Terms

Conditions

Premature Birth; Fetal Growth Retardation

Interventions

Time-Lapse Imaging; Electroencephalography

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Photography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Diagnostic Techniques, Neurological; Electrodiagnosis

Study Officials

• Valerie BIRAN, MD

  APHP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valerie BIRAN, MD

CONTACT

+33 1 40 03 41 91; valerie.biran@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: April 23, 2025
• Study Start: November 28, 2025
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2030
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

FR (1)