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

NCT06111898 | Recruiting

• 1 other identifier: 2023-01113
• Study Type: observational
• Target: 348
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Brain Imaging; General Movements; 3D freehand ultrasound; Muscle Morphology; Electromyography

Outcome Measures

Primary Outcomes (6)

• 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)

  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.

  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

  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

  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.

  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.

  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

  3 months (corrected) age, 6 months (corrected) age and 12 months (corrected) age.

• Alberta Infant Motor Scale (AIMS)

  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

Study Arms (2)

High-risk infants

Other: No Intervention

Typically developing infants

Other: No Intervention

Interventions

No Intervention OTHER

No intervention

High-risk infants; Typically developing infants

Eligibility Criteria

• Age: 35 Weeks - 1 Year
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Preterm or a term born Infants with detectable risk factors for neurodevelopmental impairments will be enrolled

You may not qualify if:

• 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
• Born at a gestational age above 37 weeks
• Birth weight between P10 and P90
• Head circumference between P10 and P90
• Ph \>7.1

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

University Hospitals Geneva

Geneva, 1205, Switzerland

RECRUITING

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Related Links

• Grant description

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Mental Disorders; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Nathalie De Beukelaer, PhD

CONTACT

+41783033552; nathalie.debeukelaer@unige.ch

Stéphane Armand, PhD

CONTACT

stephane.armand@unige.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: November 1, 2023
• Study Start: October 10, 2023
• Primary Completion: March 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 15, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: Upon publication

Locations

CH (1)