Longitudinal Development of Behavior and Its Underlying Neural Correlates in Human Infants (MultiLongDev)

Civil Hospices of Lyon

Status: Completed

Conditions: Healthy Volunteers

Treatments: Other: Infant Behavior Questionnaire Revised (IBQ-R); Other: MRI/DTI; Other: EEG; Other: The Brief Fear of Negative Evaluation Scale (BFNE); Other: Beck Depression Inventory (BDI); Other: Eye Tracking; Other: Ages and Stages Questionnaire (ASQ); Other: Edinburgh Postnatal Depression Scale

Study type: Interventional

Funder types: Other

Identifiers

NCT05167565

2021-A02238-33 (Other Identifier)

69HCL21_0921

Details and patient eligibility

About

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

Enrollment: 80 patients

Sex: All

Ages: 3+ months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Infants aged around 3 month

Experimental group

Description:

80 infants aged around 3 months will be included in this study up to around 12.5 months

Treatment:

Other: Edinburgh Postnatal Depression Scale

Other: Ages and Stages Questionnaire (ASQ)

Other: Eye Tracking

Other: The Brief Fear of Negative Evaluation Scale (BFNE)

Other: Beck Depression Inventory (BDI)

Other: EEG

Other: Infant Behavior Questionnaire Revised (IBQ-R)

Other: MRI/DTI