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Study identifier: NCT06027645 Synced from ClinicalTrials.gov · July 29, 2026
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Early Intervention Based on Neonatal Crawling in Very Premature Infants at Risk For Neurodevelopmental Disorder

Condition: Prematurity · Extreme Prematurity · Infant Development  ·  Sponsor: Marianne Barbu-Roth

PhaseNA
Planned participants50
Who can joinAll sexes, 39 Weeks to 42 Weeks
Healthy volunteersNo

About this study

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 t…

This description comes directly from the study's public registry record.

Talk to the study team

Marianne Barbu-Roth, PhD  ·  00336 18 61 09 15  ·  barburoth@gmail.com

Elodie Hinnekens, PT, PhD  ·  00336 31 75 24 20  ·  elodie.hinnekens@gmail.com

Always discuss trial participation with your own doctor first.

Locations (3)

Hôpital Paris Saint-JosephParis, FranceRecruiting
Cnrs Umr 8002Paris, Île-de-France Region, FranceRecruiting
Hôpital Robert DebréParis, Île-de-France Region, FranceRecruiting

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Source record: clinicaltrials.gov/study/NCT06027645