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NCT Number: NCT06180291

EARLY Intervention in Parent-professional Cooperation in Cerebral Palsy

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

Up to 3 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH de Annecy, Annecy, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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))

Treatment and study plan

PRECOP program

Other

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 primarily at home
  • Monitoring of psychomotor development
  • Screening for possible cerebral palsy
  • Comprehensive support for the child's development: weight, diet, sleep...
  • Reeducation, implementation of SMART type objectives (Specific, Measurable, Achievable, Achievable, Timely defined) determined with parents
  • Creation of equipment if necessary: early seating installation in particular
  • Parental support and guidance for optimizing early care
  • Parental psychological support.

Primary outcomes

  1. Score of the Total Motor Index at PDMS-3 scale (Peabody Developmental Motor Scales).

    Time frame: 24 months

    Score of the Total Motor Index at PDMS-3 scale (Peabody Developmental Motor Scales).The Total Motor Index results from the combination of Gross Motor Index and Fine Motor Index scores at PDMS-3. The functional impact of cerebral palsy at 2 years is assessed by the PDMS-3 at 24 months of age will be estimated in each of the two groups by a mean value with a 95% confidence interval.

Secondary outcomes

  1. Motor development

    Time frame: 24 months

    The assessment of motor development will be completed by taking the Global Functional Motor Assessment (EMFG) Scale ranging from 0 to 3, with 3 being the best.

  2. Cognitive development

    Time frame: 24 months

    Cognitive development will be measured by the Ages and Stages Questionnaire (ASQ)

  3. Nutritional development

    Time frame: 24 months

    Nutritional development will be assessed by the Montreal Children's Hospital (MCH) Eating Scale Scale ranging from 1 to 7, with the best score depending on each item.

  4. Development of Production Language in French (DLPF) questionnaire

    Time frame: 24 months

    The development of communication and language will be assessed through the Development of Production Language in French (DLPF) questionnaire

  5. Early relational problems

    Time frame: 24 months

    Early relational problems will be detected by Modified Checklist for Autism in Toddlers (M CHAT)

  6. Parental stress

    Time frame: 24 months

    Parental stress will be measured at 24 months of the child by the Parental Stress Scale (ESP for "Echelle de Stress Parental" in french).

    Scale ranging from 1 to 5, with the best score depending on each item.

  7. Implemented intervention and fidelity to the planned intervention at the center level

    Time frame: through study completion, an average of 42 months

    Number of professionals trained and profile of professionals, human, material and organizational resources mobilized.

  8. Intervention implemented and fidelity to the planned intervention at the patient level

    Time frame: through study completion, an average of 42 months

    Number of components of the intervention received, compliance with the frequency of interventions and deadlines in relation to the course planned to achieve the child's objectives.

  9. Parental adherence

    Time frame: through study completion, an average of 42 months

    Parental adherence to the recommendations given in the PRECOP program evaluated according to the number of sessions not carried out or canceled by the parents.

  10. Acceptability of the intervention

    Time frame: through study completion, an average of 42 months

    Acceptability from the parents' and professionals point of view, assessed by a questionnaire constructed for the study.

  11. Program transferability using PIET model: Population, Intervention, Environment, Transfer

    Time frame: through study completion, an average of 42 months

    Assessing whether PRECOP programm can be transferred from the "primary context" (the context of the intervention as it was performed in the original study) to the "target context" (the context that the intervention is aimed at being performed in) using PIET model : Population, Intervention, Environment, Transfer.

  12. Cost ratio impact

    Time frame: 12, 24 and 36 months

    Differential cost ratio resulting from the PRECOP strategy compared to the management of the control group.

  13. Annual cost impact

    Time frame: 12, 24 and 36 months

    Average annual cost of support for the financier depending on the pricing methods.

  14. Budgetary impact

    Time frame: 12, 24 and 36 months

    Estimating annual net budget up to 3 years according to trial data, literature and expert opinion.

Study contacts

Contact information is provided by the study sponsor or research team.

Julie HAESEBAERT, PhD

CONTACT

[email protected]

0472115165 ext. +33

Virginie MOURON, MD

CONTACT

[email protected]

0472004156 ext. +33

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study 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.

Acronym: PRECOP

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Dec 22, 2023
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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