Crawling intervention for very premature infants at risk for developmental delays
Effects of Early Crawling Training Via a Mini-Skateboard on the Motor Development of Very Premature Infants at Risk For Neurodevelopmental Disorder
This study is testing a new crawling method using a mini skateboard to see if it helps very premature infants improve their movement and brain development.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 39 Weeks to 42 Weeks |
| Sex | All |
| Sponsor | Centre National de la Recherche Scientifique, France Academic / other |
| Locations | 3 sites (Paris and 2 other locations) |
| Trial ID | NCT06027645 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of early crawling intervention using a specially designed mini skateboard, the Crawliskate, in very premature infants who are at high risk for neurodevelopmental disorders. The researchers will compare two groups of infants to determine if this method can enhance their motor and neuropsychological development. The intervention is based on previous findings that suggest crawling can significantly stimulate motor skills in typical newborns. By focusing on infants born between 24-32 weeks of gestation, the study seeks to provide a novel approach to early intervention in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates include very premature infants born between 24-32 weeks of gestation who are at risk for developmental delays.
Not a fit: Patients with significant medical conditions, such as bronchodysplasia or visual/auditory impairments, may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve motor and cognitive development outcomes for very premature infants.
How similar studies have performed: Previous studies have shown promise in using crawling interventions for typical newborns, but this specific approach in very premature infants is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Paris and 2 other locations
- Hôpital Paris Saint-Joseph — Paris, France (Recruiting)
- Cnrs Umr 8002 — Paris, Île-de-France Region, France (Recruiting)
- Hôpital Robert Debré — Paris, Île-de-France Region, France (Recruiting)
Study contacts
- Principal investigator: Valérie Biran, MD, PhD — Aphp
- Study coordinator: Marianne Barbu-Roth, PhD
- Email: barburoth@gmail.com
- Phone: 00336 18 61 09 15
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.