Clinical trial NCT05167565: Longitudinal Development of Behavior and Its Underlying Neural Correlates in Human Infants
Official title: Prospective Study to Investigate Changes in Both Brain and Behavior and Its Underlying Neural Correlates in Human Infants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Volunteers
Keywords: Beta burst activity
Cognitive and motor development
MRI
EEG
behavioral test
Diffusion tensor imaging (DTI)
beta bursts
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-12-22
Enrollment: 80
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The unique importance of human brain development during the first years of life is unquestionable. During an infant's first year, the brain undergoes its most dramatic structural and functional changes, with factors such as early social experience having a significant effect on this development. This study proposes to investigate changes in both brain and behavior across the first 12 months of life. At three time points (\~3, 6, and 12 month), anatomical and diffusion magnetic resonance imaging (MRI), resting state functional magnetic resonance imaging (fMRI), electroencephalography (EEG), eye tracking, and observational data will be obtained from the same sample of infants. These measures will be used to track the development of important sensorimotor, socio-emotional, and cognitive skills and their underlying neural correlates, as well as investigate the effects of early social experience on specific aspects of this development


Eligibility criteria: Inclusion Criteria:

* Healthy newborns, boys and girls, aged 3 months
* Uncomplicated pregnancy and delivery, APGAR scores \>8
* Full-term birth without identified neuromotor problems at birth
* No congenital or developmental anomalies affecting the brain
* No reported history of neurological disorders or learning disabilities in the infants
* No reported specific visual, developmental and cognitive impairment
* Absence of medication having a cerebral or psychological impact
* Both parents/ legal guardian must provide their consent and signature prior to participation of their infant in the study

Exclusion Criteria:

* Severe congenital malformation
* Infants requiring a corrective surgery
* Any refusal of a parent
* Infants with severe impairment of the general condition and vital functions
* Infants with dermatitis of the face or scalp
* Infants who receive neurological treatment
* Infants born pre-term (birth before 37 weeks gestation)
* Infants whose mothers have significant medical conditions and/or had significant complications during pregnancy
* Infants who are adopted,
* Infants who have a first degree relative with autism, intellectual disability, schizophrenia, or bipolar disorder,
* Infants who have any significant medical and/or genetic conditions affecting growth, development, or cognition,
* Infants who have any contraindication to MRI (metallic object, surgical material like cochlear implant)
* Maternal pre- eclampsia, placental abruption, maternal HIV status, and maternal alcohol or illicit drug use during pregnancy.

Primary outcomes:
measure: Fractional anisotropy
timeFrame: 9 months following the inclusion
measure: Diffusivity
timeFrame: 9 months following the inclusion
measure: Regional myelination
timeFrame: 9 months following the inclusion
Secondary outcomes:
measure: Motor beta burst timing
timeFrame: 9 months following the inclusion
measure: Motor beta burst peak frequency
timeFrame: 9 months following the inclusion
measure: Infant eye movement attentional bias
timeFrame: 9 months following the inclusion
measure: Ages and Stages Questionnaire scores
timeFrame: 9 months following the inclusion
measure: Infant Behavioral Questionnaire Revised score
timeFrame: 9 months following the inclusion
measure: Brief Fear of Negative Evaluation total score
timeFrame: 9 months following the inclusion
measure: Edinburgh Postnatal Depression Scale total score
timeFrame: 9 months following the inclusion
Other outcomes:
Locations:
city: Bron
country: France
facility: Institut des Sciences Cognitives (ISC) Laboratoire CNRS UMR6229
Study officials:
References: