Early Intervention Based on Neonatal Crawling in Very Premature Infants at Risk For Neurodevelopmental Disorder
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: Crawling stimulation with a mini-skateboard (i.e. the crawliskate).
- Who it may be relevant to
- Registry conditions: Prematurity, Extreme Prematurity, Infant Development, Brain Damage. Basic parameters: 39 Weeks — 42 Weeks · 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
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of Early Crawling Training Via a Mini-Skateboard on the Motor Development of Very Premature Infants at Risk For Neurodevelopmental Disorder
Overview
Extreme prematurity is constantly increasing according to the World Health Organization. However, methods to train premature infants at risk of disability is sorely lacking. The goal of this project is to overcome this problem. In previous studies, the investigators discovered that promoting the crawling of typical newborns on a mini skateboard, the Crawliskate (a new tool that the investigators designed and patented EP2974624A1), is an excellent way to stimulate infants' motor and locomotor development. This method is a promising way to provide early interventions in infants at heightened risk for developmental delay, such as premature infants. The specific objective of this study is to determine if early training in crawling on this mini skateboard will accelerate motor (particularly locomotor) and/or neuropsychological development in very premature infants identified as high risk for developmental delay. Methodology: The investigators will study and follow two groups of very premature infants born between 24 and 26 weeks of gestational age or born between 26 and 32 with major brain lesions. These infants will be recruited before their hospital discharge at the NICU. After their discharge from the hospital, one group of infants will be trained at home by their parents under the supervision of physiotherapists to crawl on the Crawliskate every day for 2 months (Crawli group), and one group of infants will receive regular medical care (Control group). All infants will be tested for: 1)their crawling proficiency on the Crawliskate at term-equivalent age (just before training for the trained groups) and at 2 and 6 months corrected age (CA, i.e., age determined from the date on which they should have been born), 2) their motor proficiency between 2 and 12 months CA (2D and 3D recording of head control, sitting, crawling, stepping, walking) and 3) their neurodevelopmental, motor and neuropsychological development between 0 and 28 months CA: BSID III edition, ASQ-3, Amiel-Tison's Neurological Assessment, Prechtl Assessment of general movements. One more ASQ-3 questionnaire will be provided at five years. Expected results: The first research hypothesis is that premature infants trained daily to crawl (for two months after discharge from the NICU) will acquire proficient crawling patterns and develop earlier and more effective motor and neuropsychological development than premature infants who receive no training.
Interventions
- Behavioral Crawling stimulation with a mini-skateboard (i.e. the crawliskate)
Consists of 8 weeks of daily training. Infants benefit from a 10 minutes session everyday at home with either a trained therapist or his/her parents. Parents are trained by the therapist at the begining of the 8 weeks. During each session the infant is prone wrapped on a mini-skateboard (i.e. the crawliskate) and has to produce flexion and extension movements with his four limbs in order to move forward with the assistance of the adult (therapist or parent).
Primary outcome measures
- Gross motor score from the Bayley Scale of Infant and toddlers Development III ed. [Time frame: 12 months corrected age]
Secondary outcome measures (5)
- Amiel-Tison Neurological Assessment [Time frame: at 39-42 gestational age, 2, 9, 12 months corrected age]
- Prechtl assessment [Time frame: at 39-42 gestational age and 2 months corrected age]
- Age and Stage questionnaire (ASQ) 3 [Time frame: 2, 6, 9, 12, 18, 28 corrected age and 5 years]
- 2D & 3D analysis of movement [Time frame: at 39-42 gestational age, 2, 6, 9, 12 months corrected age]
- Fine and gross motor scores from the Bayley Scale of Infant and toddlers development III ed. [Time frame: 2, 6, 9, 12, 24 months corrected age]
Eligibility criteria
Inclusion criteria
- Term between 24-26 GA or 26-32 GA with suspected brain lesion
- parental consent
- family living in intervention area
- good tolerance on the first crawliskate trial
Exclusion criteria
- no bronchodysplasia defined by oxygen dependency after 36 GA
- no medical disease
- no limb deformity
- no karyotype anomaly
- no visual or auditory impairment
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
France · 3 centers
- Hôpital Paris Saint-Joseph — Paris
- Cnrs Umr 8002 — Paris
- Hôpital Robert Debré — Paris
Identifiers
NCT: NCT06027645 · Premalocom2