Status:
RECRUITING
EARLY Intervention in Parent-professional Cooperation in Cerebral Palsy
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Cerebral Palsy
Eligibility:
All Genders
Up to 3 years
Phase:
NA
Brief Summary
Cerebral Palsy (CP) is the most common motor disability in children. It is due to damage that occurs during brain development in the fetus or infant. Early treatment (before 2 years) will allow the ch...
Eligibility Criteria
Inclusion
- New born presenting on transfontanellar ultrasound and confirmed on brain MRI (magnetic resonance imaging) at least one of the following brain lesions at high risk of cerebral palsy :
- Stage 3 intraventricular hemorrhage, requiring at least 2 subtractive lumbar punctures and/or the establishment of a ventriculoperitoneal bypass
- Stage 4 intraventricular hemorrhage
- Periventricular leukomalacia : extensive unilateral or bilateral
- Sequelae of perinatal anoxo-ischemic encephalopathy
- Extensive neonatal stroke
- Less than 3 months old (corrected age in case of prematurity)
- Hospitalized in neonatology or hospitalized in pediatric intensive care unit or within two months following return home (follow-up visit after initial hospitalization)
- Affiliate to social security
- Parental or legal representative consent to participate in the study (free and informed written consent)
Exclusion
- Children who have had an Antenatal Diagnosis of a pathology causing fear of the onset of developmental delay
- Children presenting with a congenital pathology with neonatal revelation, whether of metabolic, genetic or malformative origin
- Palliative care offered by the neonatology team (LATA: Limitation and Discontinuation of Active Therapeutics)
- Children participating simultaneously in another screening and early care program (excluding the COCON program (Soins préCOces et COordonnés du Nouveau-né vulnérable))
Key Trial Info
Start Date :
March 14 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT06180291
Start Date
March 14 2025
End Date
October 1 2028
Last Update
April 6 2025
Active Locations (8)
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1
CH de Annecy
Annecy, France, 74370
2
Service de Réanimation et médecine néonatale
Chambéry, France, 73011
3
Service de Réanimation Néonatale, Hôpital de la Croix-Rousse, Hospices Civils de Lyon
Lyon, France, 69317
4
Service de néonatologie et de réanimation néonatale, Hôpital Femme Mère Enfant, Hospices Civils de Lyon
Lyon, France, 69677