Clinical trial NCT06180291: EARLY Intervention in Parent-professional Cooperation in Cerebral Palsy
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Keywords: early intervention program
functional impact
cerebral palsy
children
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-12-22
Enrollment: 66
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective multicenter comparative non-randomized study evaluating the effectiveness of a new management strategy for children at high risk of cerebral palsy compared to the management of the control group.

The research will take place in 8 centers, 4 centers offering early intervention (Lyon Croix-Rousse, Lyon Hôpital Femme-Mère-Enfant, Montpellier, Nîmes), and 4 centers not offering standardized early intervention (Toulouse neonatal care unit, Toulouse pediatric intensive care unit, Chambéry and Annecy). The control centers were recruited on the basis of common characteristics of neonatology level of care and active queue.

Each center will consecutively include newborns during the neonatology stay. The study will compare the intervention group composed of children cared for in intervention centers to the control group composed of children cared for in control centers.
Primary purpose: SCREENING

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 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 criteria: 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))

Primary outcomes:
measure: Score of the Total Motor Index at PDMS-3 scale (Peabody Developmental Motor Scales).
timeFrame: 24 months
Secondary outcomes:
measure: Motor development
timeFrame: 24 months
measure: Cognitive development
timeFrame: 24 months
measure: Nutritional development
timeFrame: 24 months
measure: Development of Production Language in French (DLPF) questionnaire
timeFrame: 24 months
measure: Early relational problems
timeFrame: 24 months
measure: Parental stress
timeFrame: 24 months
measure: Implemented intervention and fidelity to the planned intervention at the center level
timeFrame: through study completion, an average of 42 months
measure: Intervention implemented and fidelity to the planned intervention at the patient level
timeFrame: through study completion, an average of 42 months
measure: Parental adherence
timeFrame: through study completion, an average of 42 months
measure: Acceptability of the intervention
timeFrame: through study completion, an average of 42 months
measure: Program transferability using PIET model: Population, Intervention, Environment, Transfer
timeFrame: through study completion, an average of 42 months
measure: Cost ratio impact
timeFrame: 12, 24 and 36 months
measure: Annual cost impact
timeFrame: 12, 24 and 36 months
measure: Budgetary impact
timeFrame: 12, 24 and 36 months
Other outcomes:
Locations:
city: Annecy
country: France
facility: CH de Annecy
city: Chambery
country: France
facility: Service de Réanimation et médecine néonatale
city: Lyon
country: France
facility: Service de Réanimation Néonatale, Hôpital de la Croix-Rousse, Hospices Civils de Lyon
city: Lyon
country: France
facility: Service de néonatologie et de réanimation néonatale, Hôpital Femme Mère Enfant, Hospices Civils de Lyon
city: Montpellier
country: France
facility: Service de néonatologie et de réanimation néonatale, CHU Saint-ELOI
city: Nîmes
country: France
facility: Service de néonatologie et de réanimation néonatale, Hôpital Universitaire Carémeau
city: Toulouse
country: France
facility: Service de réanimation pédiatrique, Hôpital des enfants
city: Toulouse
country: France
facility: Service de néonatologie, Hôpital des enfants
Study officials:
affiliation: Service de Réanimation Néonatale, Hôpital de la Croix-Rousse, Hospices Civils de Lyon
name: Virginie MOURON, MD
role: PRINCIPAL_INVESTIGATOR
References: