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EARLY Intervention in Parent-professional Cooperation in Cerebral Palsy

Key facts

Who runs it
Hospices Civils de Lyon
Where
France8 sites in 1 countryChoose a country to see its 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))

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

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.

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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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data 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