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Clinical Trials/NCT06111898
NCT06111898
Recruiting
N/A

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

University Hospital, Geneva1 site in 1 country348 target enrollmentOctober 10, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Premature Birth
Sponsor
University Hospital, Geneva
Enrollment
348
Locations
1
Primary Endpoint
Hammersmith Neonatal/Infant Neurological Examination
Status
Recruiting
Last Updated
2 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
October 10, 2023
End Date
December 31, 2027
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Stephane ARMAND

Professor

University Hospital, Geneva

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Hammersmith Neonatal/Infant Neurological Examination

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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 Outcomes

  • Bayley Scales of Infant and Toddler Development - Version III(3 months (corrected) age, 6 months (corrected) age and 12 months (corrected) age.)
  • Magnetic resonance imaging of the brain: classification(up to 4 weeks post-term age)
  • Magnetic resonance imaging of the brain: quantification(up to 4 weeks post-term age)
  • Alberta Infant Motor Scale (AIMS)(3 months (corrected) age, 6 months (corrected) age and 12 months (corrected) age.)

Study Sites (1)

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