Neonatal Precursors of Neurodevelopment

Study Overview
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Brief Summary
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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.

Official Title
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Neonatal Precursors of Neurodevelopment

Conditions
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Premature Birth

Intervention / Treatment
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* Device: Electroencephalography-Near infrared spectroscopy
* Device: Magnetic resonance imaging
* Behavioral: Psychometric testing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: Longitudinal study with measures at birth and at age 2.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All participants<br>All participants undergo the same measurements (longitudinal design) | Device: Electroencephalography-Near infrared spectroscopy<br>* Brain activity will be measured using 128-channel EEG and 2 channel NIRS during tactile stimulation (15 minutes sequence of vibrations) while the newborn is asleep.<br>Device: Magnetic resonance imaging<br>* Structural (T1-T2), siffusion tensor imaging and blood-oxygen level dependant signal will be acquired in a subset of 40 subjects (20 minutes while asleep)<br>Behavioral: Psychometric testing<br>* Cognitive evaluation at age 2 (Parental questionnaires on sensory profiles, executive functions and neurodevelopmental disorders screening, child tests : movement assessment battery, Laby, Head-toes-shoulders-knees)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electroencephalography evoked response amplitude | Electrical field potential changes in the parietal and frontal cortices | 35 weeks of gestational age | 
| Near infrared spectroscopy evoked response amplitude | Oxygenated hemoglobin concentration changes in the somatosensory cortex | 35 weeks of gestational age | 
| Grey matter volume in the somatosensory cortex | Thickness measured on T2 images in magnetic resonance imaging | 35 weeks GA | 
| Frontal-parietal structural connectivity | Tractography using Diffusion tensor Imaging in magnetic resonance imaging | 35 weeks GA | 
| Frontal-parietal functional connectivity | Synchronization at rest using blood-oxygen level dependent signal in magnetic resonance imaging | 35 weeks GA | 
| Quality of cognitive development | Qualitative composite assessment using clinical interview, routine pediatric screening and questionnaires (full sensory profile, preschooler Behavior Rating Inventory of Executive Function) | 2 years old |