EARLY Intervention in Parent-professional Cooperation in Cerebral Palsy

NCT06180291 · tracked via the Priya Life Science France tracker

Sponsor

Hospices Civils de Lyon

Phase

Not applicable

Started

2025-03-14

Last updated

2026-04-24

Condition(s) studied

Cerebral Palsy

Investigational drug(s) / intervention(s)

PRECOP program

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.

Study 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.

Eligibility

Sex

ALL

Min age

—

Max age

3 Months

Healthy volunteers

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))

Primary outcome measure(s)

Score of the Total Motor Index at PDMS-3 scale (Peabody Developmental Motor Scales). — 24 months
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.

Trial sites (8)

Facility	City	Region	Status
CH de Annecy	Annecy	France	Recruiting
Service de Réanimation et médecine néonatale	Chambéry	France	Recruiting
Service de Réanimation Néonatale, Hôpital de la Croix-Rousse, Hospices Civils de Lyon	Lyon	France	Recruiting
Service de néonatologie et de réanimation néonatale, Hôpital Femme Mère Enfant, Hospices Civils de Lyon	Lyon	France	Recruiting
Service de néonatologie et de réanimation néonatale, CHU Saint-ELOI	Montpellier	France	Recruiting
Service de néonatologie et de réanimation néonatale, Hôpital Universitaire Carémeau	Nîmes	France	Recruiting
Service de réanimation pédiatrique, Hôpital des enfants	Toulouse	France	Recruiting
Service de néonatologie, Hôpital des enfants	Toulouse	France	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06180291 on ClinicalTrials.gov ↗ ← All trials in France