Premature BirthBAMBINCT06111898
Neuro-biomechanical Determinants for Motor Behavior in High-risk Infants
An observational study of Premature Birth and Cerebral Palsy, run by University Hospital, Geneva at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 35 weeks to 1 yearHealthy volunteers can take part
- Conditions the study is for
- Premature Birth, Cerebral Palsy, Neurodevelopmental Disorders
- How many people
- 348 participants
- Where
- 1 siteSwitzerland
- Study dates
- 10 Oct 2023to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 weeks to 1 year
- All sexes
- Healthy volunteers accepted
- Child
Study population: Preterm or a term born Infants with detectable risk factors for neurodevelopmental impairments will be enrolled
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Stéphane Armand, PhD contact
Switzerland1 site, 1 recruiting
- Recruiting
University Hospitals Geneva
Geneva, 1205
Nathalie De Beukelaer, PhD, +41783033552, nathalie.debeukelaer@unige.ch
Stéphane Armand, PhD
About this study
Official title: Neuro-biomechanical Aspects Determining the Motor Behavior in Infants With High-risk of Neuromotor Impairments
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.
Read the 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
- Conditions
- Premature Birth, Cerebral Palsy, Neurodevelopmental Disorders, Brain Injuries, Nervous System Diseases
- Being tested
- No Intervention
- Keywords
- Brain Imaging, General Movements, 3D freehand ultrasound, Muscle Morphology, Electromyography
- Medical subject headings
- Premature Birth, Cerebral Palsy, Neurodevelopmental Disorders, Brain Injuries, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| High-risk infants | Not described Receives: Other: No Intervention | |
| Typically developing infants | Not described Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
General Movement Assessment
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)
Measured: 35-36 weeks of gestation; term equivalent age, 3 months (corrected) age
Hammersmith Neonatal/Infant Neurological Examination
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.
Measured: 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
The size of the lower leg muscles defined by freehand ultrasound
Measured: 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
The length of the lower leg muscles defined by freehand ultrasound
Measured: 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
Investigation of the muscle activity during spontaneous, whole body movements by using surface electromyography.
Measured: 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
Investigation movement quality/quantify during spontaneous, whole body movements by using reflective markers.
Measured: 35-36 weeks of gestation; term equivalent age, 3 months (corrected) age, 6 months (corrected) age and 12 months (corrected) age.
Secondary outcomes (4)
Bayley Scales of Infant and Toddler Development - Version III
Standardized neurodevelopmental test of gross and fine motor skills. Higher scores indicate better outcome.
Measured: 3 months (corrected) age, 6 months (corrected) age and 12 months (corrected) age.
Alberta Infant Motor Scale (AIMS)
Assessment of gross motor development during prone, supine, sitting and standing. Scores from 0-60. Higher scores indicate better outcome.
Measured: 3 months (corrected) age, 6 months (corrected) age and 12 months (corrected) age.
Magnetic resonance imaging of the brain: classification
Qualitatively assessment on the MRI classification system by Himmelman et al. to classify the nature of brain abnormalities.
Measured: up to 4 weeks post-term age
Magnetic resonance imaging of the brain: quantification
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.
Measured: up to 4 weeks post-term age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start10 Oct 2023
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 348 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephane ARMAND, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06111898
- Sponsor's protocol ID
- 2023-01113
- Other IDs
- 2023
- Acronym
- BAMBI
- Status last verified
- Nov 2023
- First submitted
- 20 Oct 2023
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be made available upon publication via online repository (yareta or zenodo)
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.
PubMed 29350401Rosenbaum 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.
PubMed 17370477Gough 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.
PubMed 22364585De 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.
PubMed 36836099Willerslev-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.
PubMed 29573407
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuro-biomechanical Aspects Determining the Motor Behavior in Infants With High-risk of Neuromotor Impairments
- ClinicalTrials.gov ID
- NCT06111898
- Acronym / sponsor ID
- BAMBI / 2023-01113
- Conditions
- Premature Birth, Cerebral Palsy, Neurodevelopmental Disorders, Brain Injuries, Nervous System Diseases
- Keywords
- Brain Imaging, General Movements, 3D freehand ultrasound, Muscle Morphology, Electromyography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 348 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 1 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-risk infants | – | Other: No Intervention |
| Typically developing infants | – | Other: No Intervention |
Who may qualify
- Ages
- 35 weeks to 1 year
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Preterm or a term born Infants with detectable risk factors for neurodevelopmental impairments will be enrolled
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionNo intervention | Other | High-risk infants, Typically developing infants |
Primary outcome
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)
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
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- Background: PubMed 29350401Pascal 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.
- Background: PubMed 17370477Rosenbaum 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.
- Background: PubMed 22364585Gough 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.
- Background: PubMed 36836099De 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.
- Background: PubMed 29573407Willerslev-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.
- Grant descriptionLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The data will be made available upon publication via online repository (yareta or zenodo)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stéphane Armand, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Birth and Cerebral Palsy, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nathalie De Beukelaer, PhD (+41783033552, nathalie.debeukelaer@unige.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General Movement Assessment (time frame: 35-36 weeks of gestation; term equivalent age, 3 months (corrected) age). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06111898, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023.