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

Not Applicable

Recruiting

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

• Registration Number: NCT05167565
• Lead Sponsor: Hospices Civils de Lyon

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-11-25
• Study First Submitted QC: 2021-12-09
• Study First Posted: 2021-12-22
• Study Start: 2022-10-17
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-06
• Last Update Posted: 2023-09-07
• Primary Completion: 2025-08-17
• Study Completion: 2025-08-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Infants aged around 3 month	Eye Tracking	80 infants aged around 3 months will be included in this study up to around 12.5 months
Infants aged around 3 month	MRI/DTI	80 infants aged around 3 months will be included in this study up to around 12.5 months
Infants aged around 3 month	EEG	80 infants aged around 3 months will be included in this study up to around 12.5 months
Infants aged around 3 month	The Brief Fear of Negative Evaluation Scale (BFNE)	80 infants aged around 3 months will be included in this study up to around 12.5 months
Infants aged around 3 month	Ages and Stages Questionnaire (ASQ)	80 infants aged around 3 months will be included in this study up to around 12.5 months
Infants aged around 3 month	Infant Behavior Questionnaire Revised (IBQ-R)	80 infants aged around 3 months will be included in this study up to around 12.5 months
Infants aged around 3 month	Beck Depression Inventory (BDI)	80 infants aged around 3 months will be included in this study up to around 12.5 months
Infants aged around 3 month	Edinburgh Postnatal Depression Scale	80 infants aged around 3 months will be included in this study up to around 12.5 months

Primary Outcome Measures

Name	Time	Method
Diffusivity	9 months following the inclusion	Integrity of white matter fiber tracts assessed by DTI measures of the mean, radial, and axial diffusivity (mm2/s) along them.
Regional myelination	9 months following the inclusion	Regional myelination assessed by T1 / T2 intensity ratios.
Fractional anisotropy	9 months following the inclusion	Integrity of white matter fiber tracts assessed by DTI measures of the mean fractional anisotropy (0-1, where 0=isotropic diffusion, 1=diffusion restricted along one dimension) along them.

Secondary Outcome Measures

Name	Time	Method
Motor beta burst timing	9 months following the inclusion	The timing relative to movement onset (ms) of beta bursts in the motor cortex, measured with EEG.
Infant Behavioral Questionnaire Revised score	9 months following the inclusion	Scores on the approach, vocal reactivity, high intensity pleasure, smiling and laughter, activity level, perceptual sensitivity, sadness, distress to limitations, fear, falling reactivity / rate of recovery from distress, low intensity pleasure, cuddliness, duration and orienting, and soothability scales of the Infant Behavioral Questionnaire Revised (0-7, with high scores indicating higher levels on each temperament trait).
Brief Fear of Negative Evaluation total score	9 months following the inclusion	Total score on the Brief Fear of Negative Evaluation questionnaire (0-60, with higher scores indicating higher social anxiety)
Edinburgh Postnatal Depression Scale total score	9 months following the inclusion	Total score on the Edinburgh Postnatal Depression Scale questionnaire (0-30, with higher scores indicating more depressive symptoms)
Motor beta burst peak frequency	9 months following the inclusion	The peak frequency (Hz) of beta bursts in motor cortex, measured with EEG
Infant eye movement attentional bias	9 months following the inclusion	The proportion of time spent fixating to threatening (ABT) and positive (ABP) facial expressions relative to neutral, measured using eye-tracking.
Ages and Stages Questionnaire scores	9 months following the inclusion	Scores on the gross motor, fine motor, and personal-social aspects of the Ages and Stages Questionnaire (0-60, with higher scores indicating normal development).

Trial Locations

Locations (1)

Institut des Sciences Cognitives (ISC) Laboratoire CNRS UMR6229; 🇫🇷 Bron, France