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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
66
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.
CH de Annecy
Annecy, France
RECRUITINGService de Réanimation et médecine néonatale
Chambéry, France
RECRUITINGService de Réanimation Néonatale, Hôpital de la Croix-Rousse, Hospices Civils de Lyon
Lyon, France
RECRUITINGService de néonatologie et de réanimation néonatale, Hôpital Femme Mère Enfant, Hospices Civils de Lyon
Lyon, France
RECRUITINGService de néonatologie et de réanimation néonatale, CHU Saint-ELOI
Montpellier, France
RECRUITINGService de néonatologie et de réanimation néonatale, Hôpital Universitaire Carémeau
Nîmes, France
RECRUITINGService de réanimation pédiatrique, Hôpital des enfants
Toulouse, France
RECRUITINGService de néonatologie, Hôpital des enfants
Toulouse, France
RECRUITINGScore of the Total Motor Index at PDMS-3 scale (Peabody Developmental Motor Scales).
Score of the Total Motor Index at PDMS-3 scale (Peabody Developmental Motor Scales).The Total Motor Index results from the combination of Gross Motor Index and Fine Motor Index scores at PDMS-3. The functional impact of cerebral palsy at 2 years is assessed by the PDMS-3 at 24 months of age will be estimated in each of the two groups by a mean value with a 95% confidence interval.
Time frame: 24 months
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.
Time frame: 24 months
Cognitive development
Cognitive development will be measured by the Ages and Stages Questionnaire (ASQ)
Time frame: 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.
Time frame: 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
Time frame: 24 months
Early relational problems
Early relational problems will be detected by Modified Checklist for Autism in Toddlers (M CHAT)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12, 24 and 36 months
Annual cost impact
Average annual cost of support for the financier depending on the pricing methods.
Time frame: 12, 24 and 36 months
Budgetary impact
Estimating annual net budget up to 3 years according to trial data, literature and expert opinion.
Time frame: 12, 24 and 36 months
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