Understanding motor behavior in high-risk infants
Neuro-biomechanical Aspects Determining the Motor Behavior in Infants With High-risk of Neuromotor Impairments
University Hospital, Geneva · NCT06111898
This study is trying to understand how movement and muscle development in high-risk infants, like those born early or with brain injuries, compare to typically developing infants to help find better ways to support their growth.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 348 (estimated) |
| Ages | 35 Weeks to 1 Year |
| Sex | All |
| Sponsor | University Hospital, Geneva (other) |
| Locations | 1 site (Geneva) |
| Trial ID | NCT06111898 on ClinicalTrials.gov |
What this trial studies
This project investigates the motor development, muscle growth, and muscle activity in high-risk infants, particularly those born prematurely or with brain injuries. Using advanced techniques like 3D freehand ultrasound and electromyography, the study aims to identify the neuro-biomechanical factors that influence motor behavior during the first year of life. By comparing high-risk infants with typically developing infants, the research seeks to establish a comprehensive assessment tool for early diagnosis and intervention strategies.
Who should consider this trial
Good fit: Ideal candidates include infants born before or at 28 weeks of gestation, those with brain injuries, or term infants diagnosed with asphyxia or neonatal stroke.
Not a fit: Patients with genetic syndromes or lower limb pathologies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early diagnosis and targeted therapies for high-risk infants, enhancing their long-term neurodevelopmental outcomes.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in understanding neurodevelopmental outcomes in high-risk populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion \& exclusion criteria for group of high-risk infants: * Infants born before or at 28 weeks of gestation * Infants born after 28 weeks of gestation and with brain injury. * A term birth with the clinical diagnosis of asphyxia (ischemic event with hypothermia) or neonatal stroke * Exclusion in case of genetic syndrome, or lower limb pathology (e.g. spina bifida) Inclusion \& exclusion criteria for group of typically developing children: * Born at a gestational age above 37 weeks * Birth weight between P10 and P90 * Head circumference between P10 and P90 * Ph \>7.1 * Exclusion in case of genetic syndrome, lower limb pathology and/or brain malformations
Where this trial is running
Geneva
- University Hospitals Geneva — Geneva, Switzerland (RECRUITING)
Study contacts
- Study coordinator: Nathalie De Beukelaer, PhD
- Email: nathalie.debeukelaer@unige.ch
- Phone: +41783033552
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Premature Birth, Cerebral Palsy, Neurodevelopmental Disorders, Brain Injuries, Nervous System Diseases, Brain Imaging, General Movements, 3D freehand ultrasound