EARLY Intervention in Parent-professional Cooperation in Cerebral Palsy

NCT06180291 | Recruiting

• 1 other identifier: 69HCL22_0862
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 8

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 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.

Conditions

Cerebral Palsy

Keywords

early intervention program; functional impact; cerebral palsy; children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Motor development

  24 months

• Cognitive development

  24 months

• Nutritional development

  24 months

• Development of Production Language in French (DLPF) questionnaire

  24 months

• Early relational problems

  24 months

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

PRECOP program OTHER

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.

Intervention group

Eligibility Criteria

• Age: Up to 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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))

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (8)

CH de Annecy

Annecy, 74370, France

RECRUITING

Service de Réanimation et médecine néonatale

Chambéry, 73011, France

RECRUITING

Service de Réanimation Néonatale, Hôpital de la Croix-Rousse, Hospices Civils de Lyon

Lyon, 69317, France

RECRUITING

Service de néonatologie et de réanimation néonatale, Hôpital Femme Mère Enfant, Hospices Civils de Lyon

Lyon, 69677, France

RECRUITING

Service de néonatologie et de réanimation néonatale, CHU Saint-ELOI

Montpellier, 34295, France

RECRUITING

Service de néonatologie et de réanimation néonatale, Hôpital Universitaire Carémeau

Nîmes, 30029, France

RECRUITING

Service de réanimation pédiatrique, Hôpital des enfants

Toulouse, 31059, France

RECRUITING

Service de néonatologie, Hôpital des enfants

Toulouse, 31300, France

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Virginie MOURON, MD

  Service de Réanimation Néonatale, Hôpital de la Croix-Rousse, Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Virginie MOURON, MD

CONTACT

0472004156; Virginie.mouron@chu-lyon.fr

Julie HAESEBAERT, PhD

CONTACT

0472115165; julie.haesebaert01@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 8 centers, 4 centers offering early intervention (Lyon Croix-Rousse, Lyon Hôpital Femme-Mère-Enfant, Montpellier, Nîmes), and 4 centers not offering standardized early intervention (Toulouse neonatal care unit, Toulouse pediatric intensive care unit, Chambéry and Annecy). 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.

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: December 22, 2023
• Study Start: March 14, 2025
• Primary Completion (Estimated): September 14, 2029
• Study Completion (Estimated): September 14, 2029
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

FR (8)