EARLY Intervention in Parent-professional Cooperation in Cerebral Palsy

Last updated: April 3, 2025
Sponsor: Hospices Civils de Lyon
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cerebral Palsy

Cataplexy

Treatment

PRECOP program

Clinical Study ID

NCT06180291
69HCL22_0862
  • Ages < 3
  • All Genders

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 Criteria

Inclusion

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 highrisk of cerebral palsy :

  • Stage 3 intraventricular hemorrhage, requiring at least 2 subtractive lumbarpunctures 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 orwithin two months following return home (follow-up visit after initialhospitalization)

  • Affiliate to social security

  • Parental or legal representative consent to participate in the study (free andinformed written consent)

Exclusion

Exclusion Criteria:

  • Children who have had an Antenatal Diagnosis of a pathology causing fear of theonset of developmental delay

  • Children presenting with a congenital pathology with neonatal revelation, whether ofmetabolic, genetic or malformative origin

  • Palliative care offered by the neonatology team (LATA: Limitation andDiscontinuation of Active Therapeutics)

  • Children participating simultaneously in another screening and early care program (excluding the COCON program (Soins préCOces et COordonnés du Nouveau-névulnérable))

Study Design

Total Participants: 66
Treatment Group(s): 1
Primary Treatment: PRECOP program
Phase:
Study Start date:
March 14, 2025
Estimated Completion Date:
October 01, 2028

Connect with a study center

  • CH de Annecy

    Annecy, 74370
    France

    Site Not Available

  • Service de néonatologie et de réanimation néonatale, CHU Bordeaux Pellegrin

    Bordeaux, 33000
    France

    Site Not Available

  • Service de Réanimation et médecine néonatale

    Chambery, 73011
    France

    Site Not Available

  • Service de Réanimation Néonatale, Hôpital de la Croix-Rousse, Hospices Civils de Lyon

    Lyon, 69317
    France

    Active - Recruiting

  • Service de néonatologie et de réanimation néonatale, Hôpital Femme Mère Enfant, Hospices Civils de Lyon

    Lyon, 69677
    France

    Site Not Available

  • Service de néonatologie et de réanimation néonatale, CHU Saint-ELOI

    Montpellier, 34295
    France

    Site Not Available

  • Service de néonatologie et de réanimation néonatale, Hôpital Universitaire Carémeau

    Nîmes, 30029
    France

    Site Not Available

  • Hôpital des enfants

    Toulouse, 31300
    France

    Site Not Available

  • Service de néonatologie, Hôpital des enfants

    Toulouse, 31300
    France

    Site Not Available

  • Service de réanimation pédiatrique, Hôpital des enfants

    Toulouse, 31059
    France

    Site Not Available

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