Neonatal Precursors of Neurodevelopment
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University Hospital, Caen
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Grey matter volume in the somatosensory cortex
Study Overview
Brief Summary
The NEOPRENE project proposes to examine processes that are among the earliest precursors of cognitive functions and assess 1) the relationship between neonatal cognitive precursors and cortical structure, structural connectivity and functional connectivity at birth and 2) the relationship between neonatal cognitive precursors and neurodevelopment.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- — to 2 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Preterm newborn (born < 34 weeks + 6days)
Exclusion Criteria
- •Brain injury
- •Respiratory assistance on measurement day
- •Infection on measurement day
- •Sedation on measurement day
- •Parents < 18 years old or unable to give informed consent
Arms & Interventions
All participants
All participants undergo the same measurements (longitudinal design)
Intervention: Electroencephalography-Near infrared spectroscopy (Device)
All participants
All participants undergo the same measurements (longitudinal design)
Intervention: Magnetic resonance imaging (Device)
All participants
All participants undergo the same measurements (longitudinal design)
Intervention: Psychometric testing (Behavioral)
Outcomes
Primary Outcomes
Grey matter volume in the somatosensory cortex
Time Frame: 35 weeks GA
Thickness measured on T2 images in magnetic resonance imaging
Frontal-parietal structural connectivity
Time Frame: 35 weeks GA
Tractography using Diffusion tensor Imaging in magnetic resonance imaging
Frontal-parietal functional connectivity
Time Frame: 35 weeks GA
Synchronization at rest using blood-oxygen level dependent signal in magnetic resonance imaging
Quality of cognitive development
Time Frame: 2 years old
Qualitative composite assessment using clinical interview, routine pediatric screening and questionnaires (full sensory profile, preschooler Behavior Rating Inventory of Executive Function)
Electroencephalography evoked response amplitude
Time Frame: 35 weeks of gestational age
Electrical field potential changes in the parietal and frontal cortices
Near infrared spectroscopy evoked response amplitude
Time Frame: 35 weeks of gestational age
Oxygenated hemoglobin concentration changes in the somatosensory cortex
Secondary Outcomes
No secondary outcomes reported