Status:
RECRUITING
Early Intervention Based on Neonatal Crawling in Very Premature Infants at Risk For Neurodevelopmental Disorder
Lead Sponsor:
Marianne Barbu-Roth
Collaborating Sponsors:
Ecole Pratique des Hautes Etudes
Université Paris Cité
Conditions:
Prematurity
Extreme Prematurity
Eligibility:
All Genders
39-42 years
Phase:
NA
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 i...
Eligibility Criteria
Inclusion
- 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
- no bronchodysplasia defined by oxygen dependency after 36 GA
- no medical disease
- no limb deformity
- no karyotype anomaly
- no visual or auditory impairment
Key Trial Info
Start Date :
March 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06027645
Start Date
March 29 2021
End Date
December 31 2029
Last Update
September 13 2023
Active Locations (3)
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1
Hôpital Paris Saint-Joseph
Paris, France, 75014
2
Cnrs Umr 8002
Paris, Île-de-France Region, France, 75006
3
Hôpital Robert Debré
Paris, Île-de-France Region, France, 75019