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Recruiting NCT06111898

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

Observational Premature Birth Cerebral Palsy Neurodevelopmental Disorders Brain Injuries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No Intervention.
Who it may be relevant to
Registry conditions: Premature Birth, Cerebral Palsy, Neurodevelopmental Disorders, Brain Injuries. Basic parameters: 35 Weeks — 1 year · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Interventions

  • Other No Intervention
    No intervention

Primary outcome measures

  • General Movement Assessment [Time frame: 35-36 weeks of gestation; term equivalent age, 3 months (corrected) age]
  • 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.]
  • 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.]
  • 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.]
  • 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.]
  • 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.]
Secondary outcome measures (4)
  • Bayley Scales of Infant and Toddler Development - Version III [Time frame: 3 months (corrected) age, 6 months (corrected) age and 12 months (corrected) age.]
  • Alberta Infant Motor Scale (AIMS) [Time frame: 3 months (corrected) age, 6 months (corrected) age and 12 months (corrected) age.]
  • Magnetic resonance imaging of the brain: classification [Time frame: up to 4 weeks post-term age]
  • Magnetic resonance imaging of the brain: quantification [Time frame: up to 4 weeks post-term age]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Switzerland · 1 center
  • University Hospitals Geneva — Geneva

Publications

  • Pascal A, Govaert P, Oostra A, Naulaers G, Ortibus E, Van den Broeck C. Neurodevelopmental outcome in very preterm and very-low-birthweight infants born over the past decade: a meta-analytic review. Dev Med Child Neurol. 2018 Apr;60(4):342-355. doi: 10.1111/dmcn.13675. Epub 2018 Jan 19. PMID 29350401
  • Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14. PMID 17370477
  • Gough M, Shortland AP. Could muscle deformity in children with spastic cerebral palsy be related to an impairment of muscle growth and altered adaptation? Dev Med Child Neurol. 2012 Jun;54(6):495-9. doi: 10.1111/j.1469-8749.2012.04229.x. Epub 2012 Feb 27. PMID 22364585
  • De Beukelaer N, Vandekerckhove I, Huyghe E, Molenberghs G, Peeters N, Hanssen B, Ortibus E, Van Campenhout A, Desloovere K. Morphological Medial Gastrocnemius Muscle Growth in Ambulant Children with Spastic Cerebral Palsy: A Prospective Longitudinal Study. J Clin Med. 2023 Feb 16;12(4):1564. doi: 10.3390/jcm12041564. PMID 36836099
  • Willerslev-Olsen M, Choe Lund M, Lorentzen J, Barber L, Kofoed-Hansen M, Nielsen JB. Impaired muscle growth precedes development of increased stiffness of the triceps surae musculotendinous unit in children with cerebral palsy. Dev Med Child Neurol. 2018 Jul;60(7):672-679. doi: 10.1111/dmcn.13729. Epub 2018 Mar 24. PMID 29573407

Identifiers

NCT: NCT06111898 · 2023-01113

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗