Neuro-biomechanical Determinants for Motor Behavior in High-risk Infants
- Conditions
- Brain InjuriesCerebral PalsyPremature BirthNeurodevelopmental DisordersNervous System Diseases
- Interventions
- Other: No Intervention
- Registration Number
- NCT06111898
- Lead Sponsor
- University Hospital, Geneva
- Brief 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.
- Detailed Description
Background and rationale:
Prematurity and the associated causes of perinatal brain damage, as well as neonatal stroke and birth asphyxia, are major risk factors for neurodevelopmental disorders appearing from birth. In addition, these neuromotor disorders resulting from impaired brain development appear progressively over the course of the first year, affecting early movement and muscle growth. Therefore, early diagnosis and motor therapy are essential to improve long-term neurodevelopmental outcomes. However, in order to provide adequate strategies for these high-risk infants, it is crucial to identify the determinants of potential neuromotor deficits and their consequences on early motor behavior and developmental trajectory during the first year of life. A multimodal tool is needed to reveal the early neuro-biomechanical determinants of motor behavior in infants at high risk of neurodevelopmental disorders.
Objective(s):
* Establishing a comprehensive multimodal tool for the assessment of neuro-biomechanical determinants of motor behavior in the first year of life in high-risk infants for neurodevelopmental impairments, further referred to as "advanced muscle and movement analysis (AMMA)"
* Revealing early neuro-biomechanical determinants in high-risk infants covering the first year of life, including the time points in the neonatal period, at term age, at 3 months of (corrected) age, at 6 months of (corrected) age and at 12 months of (corrected) age, by using the AMMA
Outcome(s):
* Using valid and reliable assessments within the protocol
* Differences in neuro-biomechanical determinants between typically developing infants and high-risk infants at each time point.
* Associations between the neuro-biomechanical determinants of motor behaviour in high-risk infants at each time point
* Changes over time and interaction in the neuro-biomechanical determinants, and comparisons of these evolutions in high-risk infants with typical development.
Methodology
The current study is a national, single center (Geneva University Hospitals), observational study. This observational research will perform both cross-sectional and longitudinal data collection for cohorts of live-born infants.
The study population for this study will include children, i.e., neonates and infants between the age of 35-36 weeks of gestational age to 12 months of (corrected) age. Further, two main groups of children will be included, (a) typically developing (TD) children and (b) children at high-risk for neurodevelopmental impairments. The TD children will be used as a control group.
Procedure
Multiple study visits are planned for longitudinal data collection within the first year of life, i.e. a time of term age, at 3 months, at 6 months and 12 months of age. For the preterms, the investigators also plan to perform an assessment in the neonatal period, i.e. 35-36 weeks of gestation.
The duration of each visit session will be around 90 minutes per participant, providing also time for feeding moments and adaptation of the infant to the new environment. The visit in the neonatal period will be organized at the Neonatology Unit at HUG (Geneva University Hospitals). All visits from the term (equivalent) age will be organized in the Kinesiology Laboratory at the HUG.
In general, clinical data such as birth information, structural brain MRI and developmental assessments will be derived from the medical records.
The main procedures during each research visit are:
1. Muscle assessment: using 3D freehand ultrasound technique, measuring the lower legs muscles, assessing muscle volume and length.
2. Neuromotor development: using standardized scales, measuring the gross motor development and motor repertoire, assessing age-appropriate neuromotor development.
3. Motor behavior: using surface electromyography and motion capture system, measuring spontaneous movements, assessing the movement quality and quantity
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 348
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description High-risk infants No Intervention - Typically developing infants No Intervention -
- Primary Outcome Measures
Name Time Method 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
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)
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.
- Secondary Outcome Measures
Name Time Method Bayley Scales of Infant and Toddler Development - Version III 3 months (corrected) age, 6 months (corrected) age and 12 months (corrected) age. Standardized neurodevelopmental test of gross and fine motor skills. Higher scores indicate better outcome.
Magnetic resonance imaging of the brain: classification up to 4 weeks post-term age Qualitatively assessment on the MRI classification system by Himmelman et al. to classify the nature of brain abnormalities.
Magnetic resonance imaging of the brain: quantification up to 4 weeks post-term age Qualitatively assessment on the MRI classification system by quantitative assessment using the Kidokoro scoring system to classify the extent of white and grey matter abnormalities. Total global scores were classified as normal (0-3), mild (4-7), moderate (8-11), or severe (≥12) brain abnormalities.
Alberta Infant Motor Scale (AIMS) 3 months (corrected) age, 6 months (corrected) age and 12 months (corrected) age. Assessment of gross motor development during prone, supine, sitting and standing. Scores from 0-60. Higher scores indicate better outcome.
Trial Locations
- Locations (1)
University Hospitals Geneva
🇨🇭Geneva, Switzerland