EARLY Intervention in Parent-professional Cooperation in Cerebral Palsy

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.

Overview

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.

Interventions

• Other PRECOP program
  PRECOP program is the first program combining early detection of cerebral palsy with implementation of early interventions following the latest international recommendations (multidisciplinary program at home, with the possibility of intensive courses, coaching parental, in the first 2 years of life). This comprehensive monitoring is implemented as soon as the infant arrives at home, by a multidisciplinary team and continues during the child's first 2 years. It includes: * Follow-up organized

Primary outcome measures

• Score of the Total Motor Index at PDMS-3 scale (Peabody Developmental Motor Scales). [Time frame: 24 months]

Secondary outcome measures (12)

• Motor development [Time frame: 24 months]
• Cognitive development [Time frame: 24 months]
• Nutritional development [Time frame: 24 months]
• Development of Production Language in French (DLPF) questionnaire [Time frame: 24 months]
• Early relational problems [Time frame: 24 months]
• Parental stress [Time frame: 24 months]
• Implemented intervention and fidelity to the planned intervention at the center level [Time frame: through study completion, an average of 42 months]
• Intervention implemented and fidelity to the planned intervention at the patient level [Time frame: through study completion, an average of 42 months]
• Parental adherence [Time frame: through study completion, an average of 42 months]
• Acceptability of the intervention [Time frame: through study completion, an average of 42 months]
• Program transferability using PIET model: Population, Intervention, Environment, Transfer [Time frame: through study completion, an average of 42 months]
• Cost ratio impact [Time frame: 12, 24 and 36 months]

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))

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Screening

Study locations

France · 8 centers

• CH de Annecy — Annecy
• Service de Réanimation et médecine néonatale — Chambéry
• Service de Réanimation Néonatale, Hôpital de la Croix-Rousse, Hospices Civils de Lyon — Lyon
• Service de néonatologie et de réanimation néonatale, Hôpital Femme Mère Enfant, Hospices C — Lyon
• Service de néonatologie et de réanimation néonatale, CHU Saint-ELOI — Montpellier
• Service de néonatologie et de réanimation néonatale, Hôpital Universitaire Carémeau — Nîmes
• Service de réanimation pédiatrique, Hôpital des enfants — Toulouse
• Service de néonatologie, Hôpital des enfants — Toulouse

Identifiers

NCT: NCT06180291 · 69HCL22_0862

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗