Early intervention program for children with cerebral palsy

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.

This study is testing a new early intervention program for newborns at high risk of cerebral palsy to see if it can improve their movement, thinking, and communication skills with the help of their parents.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 66 (estimated)
• Ages: N/A to 3 Months
• Sex: All
• Sponsor: Hospices Civils de Lyon (other)
• Locations: 8 sites (Annecy and 7 other locations)
• Trial ID: NCT06180291 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are newborns under three months old with specific brain lesions identified through ultrasound and MRI that indicate a high risk of cerebral palsy.

Not a fit: Patients who have had an antenatal diagnosis of a permanent disability may not benefit from this study.

Why it matters

Potential benefit: If successful, this program could significantly improve developmental outcomes for children at risk of cerebral palsy.

How similar studies have performed: Previous international studies have shown positive outcomes with early intervention programs for cerebral palsy, suggesting that this approach is promising.

Eligibility criteria

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 this trial is running

Annecy and 7 other locations

• 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)

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

Conditions: Cerebral Palsy, early intervention program, functional impact, cerebral palsy, children