Investigating brain and behavior development in infants

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

This study looks at how healthy infants' brains and behaviors develop during their first year to see how early experiences shape their growth.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 3 Months and up
• Sex: All
• Sponsor: Hospices Civils de Lyon (other)
• Locations: 1 site (Bron)
• Trial ID: NCT05167565 on ClinicalTrials.gov

What this trial studies

This study examines the development of behavior and its neural correlates in healthy infants over their first year of life. It involves assessing brain activity and structure using MRI and EEG, alongside behavioral tests at three key developmental stages: approximately 3, 6, and 12 months. The research aims to understand how early social experiences influence cognitive, motor, and socio-emotional development. By tracking these changes, the study seeks to provide insights into the critical factors affecting infant brain development.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy newborns aged 3 months with no significant medical or developmental issues.

Not a fit: Patients who may not benefit from this study include those with severe congenital malformations or neurological disorders.

Why it matters

Potential benefit: If successful, this study could enhance our understanding of infant brain development and inform early interventions to support cognitive and motor skills.

How similar studies have performed: Other studies have successfully explored similar developmental approaches, indicating potential for valuable insights in this area.

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.

Where this trial is running

Bron

• Institut des Sciences Cognitives (ISC) Laboratoire CNRS UMR6229 — Bron, France (RECRUITING)

Study contacts

• Study coordinator: James BONAIUTO, PhD

Conditions: Healthy Volunteers, Beta burst activity, Cognitive and motor development, MRI, EEG, behavioral test, Diffusion tensor imaging, beta bursts