Impact of a Screening and Early Intervention Program on the Functional Impact of Cerebral Palsy at 2 Years in Children at High Risk of Cerebral Palsy: a Prospective Comparative Multicenter Study.

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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 child to promote brain plasticity to compensate for the effects of the lesion and reduce the severity of CP. The goals of early intervention are to increase motor, cognitive and communication skills, prevent complications and provide parental support. Most authors agree to recognize the benefit of early care by emphasizing home intervention programs with active parental participation. To date, no recommendations exist in France for the management of cerebral palsy in children under the age of two. It is therefore necessary to conduct scientific studies in this population. Based on published international studies, the PRECOP program (PREcoce intervention in parent-professional COoperation in Cerebral Palsy) consists of individualized care adapted to the specific needs of each child, from the arrival of the infant at home, by a multidisciplinary team during the child's first two years.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 3 months
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
France
CH de Annecy
NOT_YET_RECRUITING
Annecy
Service de Réanimation et médecine néonatale
NOT_YET_RECRUITING
Chambéry
Service de néonatologie et de réanimation néonatale, Hôpital Femme Mère Enfant, Hospices Civils de Lyon
NOT_YET_RECRUITING
Lyon
Service de Réanimation Néonatale, Hôpital de la Croix-Rousse, Hospices Civils de Lyon
RECRUITING
Lyon
Service de néonatologie et de réanimation néonatale, CHU Saint-ELOI
NOT_YET_RECRUITING
Montpellier
Service de néonatologie et de réanimation néonatale, Hôpital Universitaire Carémeau
NOT_YET_RECRUITING
Nîmes
Service de néonatologie, Hôpital des enfants
NOT_YET_RECRUITING
Toulouse
Service de réanimation pédiatrique, Hôpital des enfants
NOT_YET_RECRUITING
Toulouse
Contact Information
Primary
Virginie MOURON, MD
Virginie.mouron@chu-lyon.fr
0472004156
Backup
Julie HAESEBAERT, PhD
julie.haesebaert01@chu-lyon.fr
0472115165
Time Frame
Start Date: 2025-03-14
Estimated Completion Date: 2028-10-01
Participants
Target number of participants: 66
Treatments
Experimental: Intervention group
PRECOP group: screening and early treatment. CAMSP (Centre d'Action Médico-Sociale Précoce) orientation upon discharge from neonatology for immediate follow-up according to PRECOP protocol: early multidisciplinary care, with targeted objectives according to the child's needs.
No_intervention: Control group
Standard of care group: in the control centers, care includes specialized consultations organized by the perinatal network with a hospital and/or community pediatrician belonging to the network until the child is 2 years old. Cerebral palsy screening is based on clinical examination.
Related Therapeutic Areas
Sponsors
Leads: Hospices Civils de Lyon

This content was sourced from clinicaltrials.gov