Premature Birth
Conditions
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.
Interventions
DEVICEElectroencephalography-Near infrared spectroscopy
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.
DEVICEMagnetic resonance imaging
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)
BEHAVIORALPsychometric testing
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)
Sponsors
University Hospital, Caen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Longitudinal study with measures at birth and at age 2.
Eligibility
Sex/Gender
ALL
Age
No minimum to 2 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Electroencephalography evoked response amplitude | 35 weeks of gestational age | Electrical field potential changes in the parietal and frontal cortices |
| Frontal-parietal functional connectivity | 35 weeks GA | Synchronization at rest using blood-oxygen level dependent signal in magnetic resonance imaging |
| Near infrared spectroscopy evoked response amplitude | 35 weeks of gestational age | Oxygenated hemoglobin concentration changes in the somatosensory cortex |
| Grey matter volume in the somatosensory cortex | 35 weeks GA | Thickness measured on T2 images in magnetic resonance imaging |
| Frontal-parietal structural connectivity | 35 weeks GA | Tractography using Diffusion tensor Imaging in magnetic resonance imaging |
| Quality of cognitive development | 2 years old | Qualitative composite assessment using clinical interview, routine pediatric screening and questionnaires (full sensory profile, preschooler Behavior Rating Inventory of Executive Function) |
Countries
France
Outcome results
None listed