CompletedNot Applicable

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

France80 participantsStarted 2022-10-17

Plain-language 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

Who can participate

Age range

3 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Fractional anisotropy

Timeframe: 9 months following the inclusion

Diffusivity

Timeframe: 9 months following the inclusion

Regional myelination

Timeframe: 9 months following the inclusion

Trial details

NCT IDNCT05167565

SponsorHospices Civils de Lyon

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-28

View on ClinicalTrials.gov More Healthy Volunteers trials

Plain-language summary

Who can participate

Age range

3 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.