Early intervention program for children with cerebral palsy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study focuses on an early intervention program called PRECOP, designed for newborns at high risk of developing cerebral palsy. The program aims to enhance motor, cognitive, and communication skills through individualized care and active parental involvement. By starting treatment before the age of two, the study seeks to leverage brain plasticity to mitigate the effects of brain lesions. The research is particularly important as there are currently no established guidelines in France for managing cerebral palsy in very young children.

Why it matters

Who can join: the full rules

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))

Where it's running

• 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

Study contacts

• Principal investigator: Virginie MOURON, MD — Service de Réanimation Néonatale, Hôpital de la Croix-Rousse, Hospices Civils de Lyon
• Study coordinator: Virginie MOURON, MD
• Email: Virginie.mouron@chu-lyon.fr
• Phone: 0472004156

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Multisite upper limb surgery in children with unilateral cerebral palsy

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• Spinal Stimulation During Walking to See If Spasticity Lessens in Cerebral Palsy

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• Combined leg nerve blocks for kids with cerebral palsy after surgery

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• Smartphone gait checks for kids with unilateral spastic CP

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.