Premature BirthCerebral PalsyNeurodevelopmental DisordersBrain InjuriesNervous System Diseases
Investigational drug(s) / intervention(s)
No Intervention
No Intervention: No intervention
Study summary
This project focuses on motor development, muscle growth and muscle activity. Using advanced, instrumented tests such as , the link between muscles and the movement characteristics will be studied. In addition, the evolution of these neuro-biomechanical determinants during the first year of life will be investigated. The examinations are planned for a group of high-risk infants (e.g. premature birth, cases of asphyxia, etc.) compared with a group of infants with typical development.
Eligibility
Sex
ALL
Min age
35 Weeks
Max age
1 Year
Healthy volunteers
Accepted
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
Primary outcome measure(s)
General Movement Assessment — 35-36 weeks of gestation; term equivalent age, 3 months (corrected) age Observation of general movements following the Prechtl's General Movement Assessment, interpreted by observing age-specific general movement components and extracting the Motor Optimality Score (0-12, the higher, the better outcome)
Hammersmith Neonatal/Infant Neurological Examination — 35-36 weeks of gestation; term equivalent age, 3 months (corrected) age, 6 months (corrected) age and 12 months (corrected) age. Neurological assessment for different domains such as muscle tone, postures, movements and reflexes . Resulting in total scores (0-78) which can be compared to norm values, and higher scores indicate better outcome.
Change in muscle morphology size — 35-36 weeks of gestation; term equivalent age, 3 months (corrected) age, 6 months (corrected) age and 12 months (corrected) age. The size of the lower leg muscles defined by freehand ultrasound
Change in muscle morphology length — 35-36 weeks of gestation; term equivalent age, 3 months (corrected) age, 6 months (corrected) age and 12 months (corrected) age. The length of the lower leg muscles defined by freehand ultrasound
Change in muscle activity — 35-36 weeks of gestation; term equivalent age, 3 months (corrected) age, 6 months (corrected) age and 12 months (corrected) age. Investigation of the muscle activity during spontaneous, whole body movements by using surface electromyography.
Change in motor behaviour — 35-36 weeks of gestation; term equivalent age, 3 months (corrected) age, 6 months (corrected) age and 12 months (corrected) age. Investigation movement quality/quantify during spontaneous, whole body movements by using reflective markers.
Trial sites (1)
Facility
City
Region
Status
University Hospitals Geneva
Geneva
Switzerland
Recruiting
More University Hospital, Geneva trials in Switzerland
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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