NCT05167565

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

Prospective Study to Investigate Changes in Both Brain and Behavior and Its Underlying Neural Correlates in Human Infants

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 3 Months
• Healthy volunteers: Accepted

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

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
OTHER	MRI/DTI	High resolution MRI scans will be acquired from each infant at three time points (\~3, 6, and 12 months), while they are naturally asleep to measure the progressive myelination of the major brain fiber tracks, grey matter maturation, and to create generative models for source reconstruction of EEG sensor data.
OTHER	EEG	EEG will be used to record infant brain activity during reaching and grasping actions to analyze beta activity
OTHER	Eye Tracking	Infants will be presented with the experimental stimuli, which will consist of images of adults displaying different facial expressions and non-social images (e.g. a cross, a geometric pattern). This procedure is based on commonly used eye tracking paradigms designed to assess attention biases in infancy. Infant eye movement and position will be measured during stimuli presentation.
OTHER	Ages and Stages Questionnaire (ASQ)	The parents will be asked to complete the ASQ questionnaire (Developmental questionnaire). ASQ-3 has 5 aspects: Communication, Gross motor, Fine motor, Problem solving and Personal-Social Each aspect has 6 questions, if the answer is Yes, score = 10, Sometimes = 5 and Not yet = 0. ASQ-3 average = average score of 5 aspects.
OTHER	Infant Behavior Questionnaire Revised (IBQ-R)	The parents will be asked to complete the IBQ-R questionnaire (Developmental questionnaire). The 191-item instrument provides scores on 14 temperament scales which in turn cluster into 3 overarching factors: Positive Affectivity/Surgency, Negative Emotionality, and Orienting/Regulatory Capacity. Items are rated on a 7-point scale.
OTHER	Beck Depression Inventory (BDI)	The parents will be asked to complete the BDI questionnaire (Mental health questionnaire). Scale is a 21-item self-reported questionnaire which measures the existence and severity of symptoms of depression. Scores for each symptom are added up to obtain the total scores for all 21 items. Total score ranges from 0-63; of which 0-8 is considered no depression, 0-13 is minimal depression, 14-19 is mild depression, 20-28 is moderate depression and 29-63 is severe depression.
OTHER	The Brief Fear of Negative Evaluation Scale (BFNE)	The parents will be asked to complete the BFNE questionnaire (Mental health questionnaire). The BFNE measures anxiety associated with perceived negative evaluation. This scale is composed of 12 items describing fearful or worrying cognition. Scores from for each item are added up to obtain the total score.
OTHER	Edinburgh Postnatal Depression Scale	The parents will be asked to complete the Edinburgh Postnatal Depression Scale (Mental health questionnaire). This is a set of 10 screening questions that can indicate whether a parent has symptoms that are common in women with depression and anxiety during pregnancy and in the year following the birth of a child. The total score is calculated by adding the numbers selected for each of the 10 items. If the parent's score is 10 points or above, they should speak to a health professional about those symptoms.

Timeline

• Start date: 2022-10-17
• Primary completion: 2026-01-28
• Completion: 2026-01-28
• First posted: 2021-12-22
• Last updated: 2026-02-06

Locations

1 site across 1 country: France