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

Cerebral Palsy Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Brain Injuries
• Cerebral Palsy
• Nervous System Diseases
• Neurodevelopmental Disorders
• Premature Birth

• NCT number: NCT06111898
• Study type: Observational
• Source: University Hospital, Geneva
• Contact: Nathalie De Beukelaer, PhD
• Phone: +41783033552
• Email: nathalie.debeukelaer@unige.ch
• Status: Recruiting
• Start date: October 10, 2023
• Completion date: December 31, 2027