EARLY Intervention in Parent-professional Cooperation in Cerebral Palsy

Recruiting now · Not applicable

Conditions studied: Cerebral Palsy

In brief

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.

Key facts

Study ID

NCT06180291

Run by

Hospices Civils de Lyon

People needed

66

Starts

2025-03-14

Expected to finish

2029-09-14

Last updated by the study team

2026-04-24

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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 is running

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

Full record on ClinicalTrials.gov

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