- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06111898
Neuro-biomechanical Determinants for Motor Behavior in High-risk Infants (BAMBI)
Neuro-biomechanical Aspects Determining the Motor Behavior in Infants With High-risk of Neuromotor Impairments
Study Overview
Status
Conditions
Intervention / Treatment
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:
- 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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Nathalie De Beukelaer, PhD
- Phone Number: +41783033552
- Email: nathalie.debeukelaer@unige.ch
Study Contact Backup
- Name: Stéphane Armand, PhD
- Email: stephane.armand@unige.ch
Study Locations
-
-
-
Geneva, Switzerland, 1205
- Recruiting
- University Hospitals Geneva
-
Contact:
- Nathalie De Beukelaer, PhD
- Phone Number: +41783033552
- Email: nathalie.debeukelaer@unige.ch
-
Contact:
- Stéphane Armand, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
High-risk infants
|
No intervention
|
Typically developing infants
|
No intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
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.
|
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.
|
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.
|
The size of the lower leg muscles defined by freehand ultrasound
|
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.
|
The length of the lower leg muscles defined by freehand ultrasound
|
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.
|
Investigation of the muscle activity during spontaneous, whole body movements by using surface electromyography.
|
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.
|
Investigation movement quality/quantify during spontaneous, whole body movements by using reflective markers.
|
35-36 weeks of gestation; term equivalent age, 3 months (corrected) age, 6 months (corrected) age and 12 months (corrected) age.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bayley Scales of Infant and Toddler Development - Version III
Time Frame: 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.
|
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.
|
Assessment of gross motor development during prone, supine, sitting and standing.
Scores from 0-60.
Higher scores indicate better outcome.
|
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
|
Qualitatively assessment on the MRI classification system by Himmelman et al. to classify the nature of brain abnormalities.
|
up to 4 weeks post-term age
|
Magnetic resonance imaging of the brain: quantification
Time Frame: 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.
Total global scores were classified as normal (0-3), mild (4-7), moderate (8-11), or severe (≥12) brain abnormalities.
|
up to 4 weeks post-term age
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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. Erratum In: Dev Med Child Neurol. 2007 Jun;49(6):480.
- 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.
- 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.
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Wounds and Injuries
- Brain Damage, Chronic
- Craniocerebral Trauma
- Trauma, Nervous System
- Pregnancy Complications
- Obstetric Labor Complications
- Obstetric Labor, Premature
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Cerebral Palsy
- Brain Injuries
- Nervous System Diseases
- Premature Birth
- Neurodevelopmental Disorders
Other Study ID Numbers
- 2023-01113
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Nervous System Diseases
-
Bracco Diagnostics, IncCompletedCentral Nervous System Neoplasms | Central Nervous System Disease
-
Bracco Diagnostics, IncCompletedCentral Nervous System Diseases | Central Nervous System NeoplasmsUnited States
-
Bracco Diagnostics, IncCompletedCentral Nervous System Diseases | Central Nervous System NeoplasmsUnited States
-
UNC Lineberger Comprehensive Cancer CenterRecruitingCentral Nervous System TumorUnited States
-
University of MichiganCompletedAutonomic Peripheral Nervous System DiseasesUnited States
-
Washington University School of MedicineRecruitingCentral Nervous SystemUnited States
-
Weill Medical College of Cornell UniversityRecruitingCentral Nervous System Tumor | Pediatric Central Nervous System TumorUnited States
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)CompletedBrain and Central Nervous System TumorsUnited States
-
National Cancer Institute (NCI)CompletedBrain and Central Nervous System TumorsUnited States
-
Sidney Kimmel Comprehensive Cancer Center at Johns...National Cancer Institute (NCI)TerminatedBrain and Central Nervous System TumorsUnited States
Clinical Trials on No Intervention
-
Wave NeuroscienceCompletedAutistic DisorderUnited States
-
University of Alabama at BirminghamCompletedInflammatory Bowel Diseases | Colorectal Cancer | Diverticular Diseases | Social BehaviorUnited States
-
Janssen Research & Development, LLCCompletedLupus Erythematosus, Systemic | Lupus Erythematosus, Cutaneous | Lupus Erythematosus, DiscoidUnited States, Poland
-
Hospital Universitario La Paz3MVX CCB and Agaplesion Markus Krankenhaus, Frankfurt a.M., Germany.; Department...RecruitingEmbolism | Atrial Fibrillation | Arrhythmia | Stroke, Acute | Stroke Sequelae | AblationSpain
-
Southern California College of Optometry at Marshall...Ohio State University; University of Houston; Alcon Research; University of Waterloo and other collaboratorsCompletedContact Lens Complication | Contact Lens Acute Red Eye | Contact Lens Related Corneal Infiltrate (Disorder) | Contact Lens-Induced Corneal Fluorescein StainingUnited States, Canada
-
University of Dublin, Trinity CollegeCompleted
-
Hôpital Necker-Enfants MaladesUnknown
-
China Medical University HospitalUnknownIntention to Stay, Turnover Behavior
-
University of PittsburghCompletedChronic Low Back PainUnited States