BAMBI: Neuro-biomechanical Determinants for Motor Behavior in High-risk Infants

Sponsor

University Hospital, Geneva (Other)

Overall Status

Recruiting

CT.gov ID

NCT06111898

Collaborator

(none)

348

Enrollment

Location

50.7

Anticipated Duration (Months)

6.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Premature Birth Cerebral Palsy Neurodevelopmental Disorders Brain Injuries Nervous System Diseases	Other: No Intervention

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. 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:

Muscle assessment: using 3D freehand ultrasound technique, measuring the lower legs muscles, assessing muscle volume and length.
Neuromotor development: using standardized scales, measuring the gross motor development and motor repertoire, assessing age-appropriate neuromotor development.
Motor behavior: using surface electromyography and motion capture system, measuring spontaneous movements, assessing the movement quality and quantity

Study Design

Study Type:

Observational

Anticipated Enrollment :

348 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Neuro-biomechanical Aspects Determining the Motor Behavior in Infants With High-risk of Neuromotor Impairments

Actual Study Start Date :

Oct 10, 2023

Anticipated Primary Completion Date :

Mar 31, 2026

Anticipated Study Completion Date :

Dec 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
High-risk infants	Other: No Intervention No intervention
Typically developing infants	Other: No Intervention No intervention

Arm

Intervention/Treatment

High-risk infants

Other: No Intervention

No intervention

Typically developing infants

Other: No Intervention

No intervention

Outcome Measures

Primary Outcome Measures

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 spontanous, 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 spontanous, whole body movements by using reflective markers.

Secondary Outcome Measures

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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Weeks to 1 Year

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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