EARLY Intervention in Parent-professional Cooperation in Cerebral Palsy

Cerebral Palsy Clinical Trial

— PRECOP  

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06180291
• Other study ID #: 69HCL22_0862
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: September 1, 2027

Study information

• Verified date: December 2023
• Source: Hospices Civils de Lyon
• Contact: Virginie MOURON, MD
• Phone: 0472004156
• Email: Virginie.mouron[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 66
• Est. completion date: September 1, 2027
• Est. primary completion date: August 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Months

Eligibility

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))

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

Intervention

Other:
• PRECOP program
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.

Locations

Country	Name	City	State
France	Service de néonatologie et de réanimation néonatale, CHU Bordeaux Pellegrin	Bordeaux
France	Service de néonatologie et de réanimation néonatale, Hôpital Femme Mère Enfant, Hospices Civils de Lyon	Lyon
France	Service de Réanimation Néonatale, Hôpital de la Croix-Rousse, Hospices Civils de Lyon	Lyon
France	Service de néonatologie et de réanimation néonatale, CHU Saint-ELOI	Montpellier
France	Service de néonatologie et de réanimation néonatale, Hôpital Universitaire Carémeau	Nîmes
France	Hôpital des enfants	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Cognitive development	Cognitive development will be measured by the Ages and Stages Questionnaire (ASQ)	24 months
Secondary	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
Secondary	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
Secondary	Early relational problems	Early relational problems will be detected by Modified Checklist for Autism in Toddlers (M CHAT)	24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Cost ratio impact	Differential cost ratio resulting from the PRECOP strategy compared to the management of the control group.	12, 24 and 36 months
Secondary	Annual cost impact	Average annual cost of support for the financier depending on the pricing methods.	12, 24 and 36 months
Secondary	Budgetary impact	Estimating annual net budget up to 3 years according to trial data, literature and expert opinion.	12, 24 and 36 months