Quantitative 3D UltraSound Brain Imaging: Development of New Bedside Biomarkers to Better Predict Neurodevelopmental Outcomes in Preterm Infants

NCT07358819 | Not Yet Recruiting

• 2 other identifiers: APHP251518IDRCB
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

Prematurity is a leading cause of neurodevelopmental disorders (NDDs) tightly associated with white matter damage, including punctate white matter lesions (PWMLs). Hence, an improved detection of brain injury early in life in infants born very preterm is a top priority to predict NDDs and therefore to assess potential neuroprotective strategies and implement early interventions. 3D and quantitative tools at the bedside using ultrasound are expected to better detect and quantify not only PWMLs but also other brain structures with promising prognostic value to predict NDDs at 2 years of age.

Conditions

Very Preterm Infants Born < 30 Weeks of Gestation

Keywords

Very preterm infants; White matter lesions; Neurodevelopment; 3D Cranial Ultrasound; Artificial intelligence; Prediction

Outcome Measures

Primary Outcomes (1)

• Identifying new early imaging biomarkers to predict NDDs at 2 years of age.

  Correlation between 3D quantification of PWMLs burden, and results of Bayley Scale assessment, at 2 years of age and the Parent Report of Children's Abilities-Revised (PARCA-R) questionnaire, which identifies preterm children at risk for developmental delays at 24 months of age.

  2 years

Secondary Outcomes (3)

• Developing a processing pipeline allowing the reconstruction of 3D cUS volume & automatic detection and segmentation algorithms based on deep learning methods.

  Between day 3±1 and day 21±3

• Validating these models to detect PWMLs, & segment thalami and cerebral ventricular system (CVS).

  2 years

• Correlating thalami and CVS 3D longitudinal volumes in very preterm infants with & without PWMLs

  2 years

Interventions

Brain MRI RADIATION

Brain MRI at term equivalent of age for all neonates (considered as standard of care for those born before 28 weeks of gestation)

PARCA-R questionnaire OTHER

Parent Report of Children's Abilities-Revised (PARCA-R) questionnaire at 2 years

Cranial ultrasound RADIATION

Dynamic recording of cranial ultrasound assessment with AI-assisted post-processing for brain segmentation at day 3±1, day 8±2, day 21±3, 36 weeks of postmenstrual age, and term equivalent age using bedside cUS.

Eligibility Criteria

• Age: 23 Weeks - 35 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Very preterm infants delivered (either inborn or outborn) between 23+0 and 29+6 weeks of gestation
• Informed written consent of the holders of parental authority.

You may not qualify if:

• Admission for palliative care
• Chromosomal aberrations and major malformations evidenced after birth Major malformations
• Chromosomal aberrations
• No social security coverage

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Cochin Port-Royal, APHP Centre

Paris, Île-de-France Region, 75014, France

Location

Study Officials

• Olivier BAUD, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivier BAUD, MD, PhD

CONTACT

01 58 41 24 23; olivier.baud@aphp.fr

Adèle BELLINO

CONTACT

01 71 76 07 57; adele.bellino@aphp.fr

Study Design

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

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: January 22, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2031
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)