EARLY Intervention in Parent-professional Cooperation in Cerebral Palsy (PRECOP)

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.

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 Overview

• Status: Recruiting
• Conditions: Cerebral Palsy
• Intervention / Treatment: Other: PRECOP program

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Virginie MOURON, MD; Phone Number: +33 0472004156; Email: Virginie.mouron@chu-lyon.fr
• Study Contact Backup: Name: Julie HAESEBAERT, PhD; Phone Number: +33 0472115165; Email: julie.haesebaert01@chu-lyon.fr

Study Locations

• France
  • Annecy, France, 74370
    • Recruiting
    • CH de Annecy
    • Contact: Alexandra BOWER DANLOS, MD; Phone Number: +33 04 50 63 63 24; Email: abower@ch-annecygenevois.fr
  • Chambéry, France, 73011
    • Recruiting
    • Service de Réanimation et médecine néonatale
    • Contact: Nathalie BOUCHON-GUEDJ, MD; Phone Number: +33 04 79 96 51 50; Email: nathalie.bouchon-guedj@ch-metropole-savoie.fr
  • Lyon, France, 69317
    • Recruiting
    • Service de Réanimation Néonatale, Hôpital de la Croix-Rousse, Hospices Civils de Lyon
    • Contact: Virginie MOURON, MD; Phone Number: +33 04 72 00 41 56; Email: virginie.mouron@chu-lyon.fr
  • Lyon, France, 69677
    • Recruiting
    • Service de néonatologie et de réanimation néonatale, Hôpital Femme Mère Enfant, Hospices Civils de Lyon
    • Contact: Kim N'GUYEN, MD; Phone Number: +33 04 27 85 52 84; Email: huu-kim-an.nguyen@chu-lyon.fr
  • Montpellier, France, 34295
    • Recruiting
    • Service de néonatologie et de réanimation néonatale, CHU Saint-ELOI
    • Contact: Odile PLAN, MD; Phone Number: +33 04 67 33 66 09; Email: o-plan@chu-montpellier.fr
  • Nîmes, France, 30029
    • Recruiting
    • Service de néonatologie et de réanimation néonatale, Hôpital Universitaire Carémeau
    • Contact: Isabelle SOUSKI, MD; Phone Number: +33 04 66 68 33 05; Email: i.souski@perinatalite-occitanie.fr
  • Toulouse, France, 31059
    • Recruiting
    • Service de réanimation pédiatrique, Hôpital des enfants
    • Contact: Sophie BREINIG, MD; Phone Number: +33 05 34 55 84 77; Email: breinig.s@chu-toulouse.fr
  • Toulouse, France, 31300
    • Recruiting
    • Service de néonatologie, Hôpital des enfants
    • Contact: Nathalie MONTJAUX, MD; Phone Number: +33 05 34 55 84 75; Email: montjaux.n@chu-toulouse.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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))

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention 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.	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.
No Intervention: Control 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time 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 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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Virginie MOURON, MD, Service de Réanimation Néonatale, Hôpital de la Croix-Rousse, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2025
• Primary Completion (Estimated): September 14, 2029
• Study Completion (Estimated): September 14, 2029

Study Registration Dates

• First Submitted: October 23, 2023
• First Submitted That Met QC Criteria: December 20, 2023
• First Posted (Actual): December 22, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: children; cerebral palsy; early intervention program; functional impact
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: 69HCL22_0862

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No