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EARLY Intervention in Parent-professional Cooperation in Cerebral Palsy (PRECOP) 66 At-Home International

Recruiting
Clinical Trial NCT06180291 (PRECOP) is an interventional study for Cerebral Palsy that is recruiting. It started on 14 March 2025 with plans to enroll 66 participants. Led by Hospices Civils de Lyon, it is expected to complete by 1 October 2028. The latest data from ClinicalTrials.gov was last updated on 6 April 2025.
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 ...Show More
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.

Conditions
Cerebral Palsy
Other Study IDs
  • PRECOP
  • 69HCL22_0862
NCT ID Number
NCT06180291
Start Date (Actual)
2025-03-14
Last Update Posted
2025-04-06
Completion Date (Estimated)
2028-10-01
Enrollment (Estimated)
66
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
early intervention program
functional impact
cerebral palsy
children
Primary Purpose
Screening
Design Allocation
Non-Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalIntervention group
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.
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 ...Show More
No InterventionControl group
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.
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Score 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.
24 months
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime 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
Participation Assistant
Eligibility Criteria

Eligible Ages
Child
Eligible Sexes
All

  • 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)

  • 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))
Hospices Civils de Lyon logoHospices Civils de Lyon
Study Central Contact
Contact: Virginie MOURON, MD, 0472004156, [email protected]
Contact: Julie HAESEBAERT, PhD, 0472115165, [email protected]
8 Study Locations in 1 Countries
CH de Annecy, Annecy, 74370, France
Alexandra BOWER DANLOS, MD, Contact, 04 50 63 63 24, [email protected]
Not yet recruiting
Service de Réanimation et médecine néonatale, Chambéry, 73011, France
Nathalie BOUCHON-GUEDJ, MD, Contact, 04 79 96 51 50, [email protected]
Not yet recruiting
Service de Réanimation Néonatale, Hôpital de la Croix-Rousse, Hospices Civils de Lyon, Lyon, 69317, France
Virginie MOURON, MD, Contact, 04 72 00 41 56, [email protected]
Recruiting
Service de néonatologie et de réanimation néonatale, Hôpital Femme Mère Enfant, Hospices Civils de Lyon, Lyon, 69677, France
Kim N'GUYEN, MD, Contact, 04 27 85 52 84, [email protected]
Not yet recruiting
Service de néonatologie et de réanimation néonatale, CHU Saint-ELOI, Montpellier, 34295, France
Odile PLAN, MD, Contact, 04 67 33 66 09, [email protected]
Not yet recruiting
Service de néonatologie et de réanimation néonatale, Hôpital Universitaire Carémeau, Nîmes, 30029, France
Isabelle SOUSKI, MD, Contact, 04 66 68 33 05, [email protected]
Not yet recruiting
Service de réanimation pédiatrique, Hôpital des enfants, Toulouse, 31059, France
Sophie BREINIG, MD, Contact, 05 34 55 84 77, [email protected]
Not yet recruiting
Service de néonatologie, Hôpital des enfants, Toulouse, 31300, France
Nathalie MONTJAUX, MD, Contact, 05 34 55 84 75, [email protected]
Not yet recruiting