EARLY Intervention in Parent-professional Cooperation in Cerebral Palsy

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Other: PRECOP program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: New born presenting on transfontanellar ultrasound and confirmed on brain MRI (magnetic resonance imaging) at least one of the following brain lesions: Stage 3 intraventricular hemorrhage, requiring at least 2 subtractive lumbar punctures and/or the establishment of a ventriculoperitoneal bypass Stage 4 intraventricular hemorrhage Extensive unilateral or bilateral periventricular leukomalacia Sequelae of perinatal anoxo-ischemic encephalopathy Extensive neonatal stroke Less than 3 months old (corrected age in case of prematurity) Hospitalized in neonatology or within the month following return home 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))

Ages Eligible for Study
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Maximum Age: 3 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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 6 centers, 4 centers offering early intervention (Lyon Croix-Rousse, Lyon Hôpital Femme-Mère-Enfant, Montpellier, Nîmes), and 2 centers not offering standardized early intervention (Toulouse and Bordeaux). 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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. | Other: PRECOP program<br>* PRECOP program is the first program combining early detection of cerebral palsy with implementation of early interventions following the latest international recommendations (multidisciplinary program at home, with the possibility of intensive courses, coaching parental, in the first 2 years of life). This comprehensive monitoring is implemented as soon as the infant arrives at home, by a multidisciplinary team and continues during the child's first 2 years. It includes: Follow-up organized primarily at home Monitoring of psychomotor development Screening for possible cerebral palsy Comprehensive support for the child's development: weight, diet, sleep... Reeducation, implementation of SMART type objectives (Specific, Measurable, Achievable, Achievable, Timely defined) determined with parents Creation of equipment if necessary: early seating installation in particular Parental support and guidance for optimizing early care Parental psychological support.<br>|
| No Intervention: Control group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score of the Global Motor Development Quotient (QDM) at PDMS-2 scale (Peabody Developmental Motor Scales). | The functional impact of cerebral palsy at 2 years is assessed by the PDMS-2. The Global Motor Development Quotient at PDMS-2 (PDMS2-QDM) at 24 months of age will be estimated in each of the two groups by a mean value with a 95% confidence interval. Scale ranging from 0 to 2, with 2 being the best. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor development | The assessment of motor development will be completed by taking the Global Functional Motor Assessment (EMFG) Scale ranging from 0 to 3, with 3 being the best. | 24 months | 
| Cognitive development | Cognitive development will be measured by the Ages and Stages Questionnaire (ASQ) | 24 months | 
| Nutritional development | Nutritional development will be assessed by the Montreal Children's Hospital (MCH) Eating Scale Scale ranging from 1 to 7, with the best score depending on each item. | 24 months | 
| Development of Production Language in French (DLPF) questionnaire | The development of communication and language will be assessed through the Development of Production Language in French (DLPF) questionnaire | 24 months | 
| Early relational problems | Early relational problems will be detected by Modified Checklist for Autism in Toddlers (M CHAT) | 24 months | 
| Parental stress | Parental stress will be measured at 24 months of the child by the Parental Stress Scale (ESP for Echelle de Stress Parental in french). Scale ranging from 1 to 5, with the best score depending on each item. | 24 months | 
| Implemented intervention and fidelity to the planned intervention at the center level | Number of professionals trained and profile of professionals, human, material and organizational resources mobilized. | through study completion, an average of 42 months | 
| Intervention implemented and fidelity to the planned intervention at the patient level | Number of components of the intervention received, compliance with the frequency of interventions and deadlines in relation to the course planned to achieve the child's objectives. | through study completion, an average of 42 months | 
| Parental adherence | Parental adherence to the recommendations given in the PRECOP program evaluated according to the number of sessions not carried out or canceled by the parents. | through study completion, an average of 42 months | 
| Acceptability of the intervention | Acceptability from the parents' and professionals point of view, assessed by a questionnaire constructed for the study. | through study completion, an average of 42 months | 
| Program transferability using PIET model: Population, Intervention, Environment, Transfer | Assessing whether PRECOP programm can be transferred from the primary context (the context of the intervention as it was performed in the original study) to the target context (the context that the intervention is aimed at being performed in) using PIET model : Population, Intervention, Environment, Transfer. | through study completion, an average of 42 months | 
| Cost ratio impact | Differential cost ratio resulting from the PRECOP strategy compared to the management of the control group. | 12, 24 and 36 months | 
| Annual cost impact | Average annual cost of support for the financier depending on the pricing methods. | 12, 24 and 36 months | 
| Budgetary impact | Estimating annual net budget up to 3 years according to trial data, literature and expert opinion. | 12, 24 and 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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early intervention program, functional impact, cerebral palsy, children