NCT06027645 Early Intervention Based on Neonatal Crawling in Very Premature Infants at Risk For Neurodevelopmental Disorder
| NCT ID | NCT06027645 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Marianne Barbu-Roth |
| Condition | Prematurity |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2021-03-29 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2021-03-29 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Marianne Barbu-Roth, PhD
STUDY CHAIR
Centre National de la Recherche Scientifique, France
Frequently Asked Questions
Who can join the NCT06027645 clinical trial?
This trial is open to participants of all sexes, aged 39 Weeks or older, up to 42 Weeks, studying Prematurity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06027645 currently recruiting?
Yes, NCT06027645 is actively recruiting participants. Contact the research team at barburoth@gmail.com for enrollment information.
Where is the NCT06027645 trial being conducted?
This trial is being conducted at Paris, France, Paris, France, Paris, France.
Who is sponsoring the NCT06027645 clinical trial?
NCT06027645 is sponsored by Marianne Barbu-Roth. The principal investigator is Marianne Barbu-Roth, PhD at Centre National de la Recherche Scientifique, France. The trial plans to enroll 50 participants.