Ignite Creation Date:
2024-05-06 @ 7:44 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06111898
Status:
RECRUITING
Last Update Posted:
2023-11-15
First Post:
2023-10-20
Brief Title:
Neuro-biomechanical Determinants for Motor Behavior in High-risk Infants
Sponsor:
University Hospital Geneva
Organization:
University Hospital Geneva
Study Overview
Official Title:
Neuro-biomechanical Aspects Determining the Motor Behavior in Infants With High-risk of Neuromotor Impairments
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BAMBI
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 eg 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
Objectives
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
Outcomes
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 ie 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 ie 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 ie 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
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
Objectives
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
Outcomes
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 ie 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 ie 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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None