Informations générales (source: ClinicalTrials.gov)
Effects of Early Crawling Training Via a Mini-Skateboard on the Motor Development of Very Premature Infants at Risk For Neurodevelopmental Disorder (Premalocom2)
Interventional
N/A
Marianne Barbu-Roth (Voir sur ClinicalTrials)
mars 2021
décembre 2029
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| GH PARIS SITE SAINT JOSEPH | Laurence Boujenah, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Cnrs Umr 8002 - 75006 - Paris - Ile De France - France | Marianne Barbu-Roth, PhD | Contact (sur clinicalTrials) | |||
| Hôpital Robert Debré - 75019 - Paris - Ile De France - France | Valérie Biran, MD, PhD | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- no bronchodysplasia defined by oxygen dependency after 36 GA
- no medical disease
- no limb deformity
- no karyotype anomaly
- no visual or auditory impairment