EARLY Intervention in Parent-professional Cooperation in Cerebral Palsy (PRECOP)

Civil Hospices of Lyon

Status: Enrolling

Conditions: Cerebral Palsy

Treatments: Other: PRECOP program

Study type: Interventional

Funder types: Other

Identifiers

NCT06180291

69HCL22_0862

Details and patient eligibility

About

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.

Enrollment: 66 estimated patients

Sex: All

Ages: Under 3 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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))

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

Intervention group

Experimental group

Description:

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.

Treatment:

Other: PRECOP program

Control group

No Intervention group

Description:

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.