EARLY Intervention in Parent-professional Cooperation in Cerebral Palsy
Key facts
- Who runs it
- Hospices Civils de Lyon
- Where
- Annecy, Chambéry, Lyon, Montpellier, Nîmes, and Toulouse, FranceSee the 8 sites
- Trial code
- Status
- Recruiting
- People taking part
- 66 people, planned
- Started
- 14 Mar 2025
- Expected to end
- 14 Sept 2029
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- PRECOP program
- Record updated
- 24 April 2026
Who can take part
- Age
- Up to 3 months
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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)
Who cannot take part
- 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))
Where in France
- CH de AnnecyAnnecy, FranceContact: Alexandra BOWER DANLOS, MDTaking people
- Service de Réanimation et médecine néonataleChambéry, FranceContact: Nathalie BOUCHON-GUEDJ, MDTaking people
- Service de néonatologie et de réanimation néonatale, Hôpital Femme Mère Enfant, Hospices Civils de LyonLyon, FranceContact: Kim N'GUYEN, MDTaking people
- Service de Réanimation Néonatale, Hôpital de la Croix-Rousse, Hospices Civils de LyonLyon, FranceContact: Virginie MOURON, MDTaking people
- Service de néonatologie et de réanimation néonatale, CHU Saint-ELOIMontpellier, FranceContact: Odile PLAN, MDTaking people
- Service de néonatologie et de réanimation néonatale, Hôpital Universitaire CarémeauNîmes, FranceContact: Isabelle SOUSKI, MDTaking people
- Service de néonatologie, Hôpital des enfantsToulouse, FranceContact: Nathalie MONTJAUX, MDTaking people
- Service de réanimation pédiatrique, Hôpital des enfantsToulouse, FranceContact: Sophie BREINIG, MDTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- Intervention groupTreatment being tested
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.
Treatment: PRECOP program
- Control groupNo study treatment, for comparison
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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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.
- Record updated
- 24 April 2026