Actively Recruiting

Phase Not Applicable
Age: 0 - 3Months
All Genders
NCT06180291

EARLY Intervention in Parent-professional Cooperation in Cerebral Palsy

Led by Hospices Civils de Lyon · Updated on 2026-04-24

66

Participants Needed

8

Research Sites

235 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

EARLY Intervention in Parent-professional Cooperation in Cerebral Palsy

Who Can Participate

Age: 0 - 3Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Newborn with brain lesions at high risk of cerebral palsy confirmed by ultrasound and MRI including stage 3 or 4 intraventricular hemorrhage, periventricular leukomalacia, perinatal anoxo-ischemic encephalopathy sequelae, or extensive neonatal stroke
  • Less than 3 months old (corrected age if premature)
  • Hospitalized in neonatology or pediatric intensive care unit, or within two months after returning home
  • Affiliated with social security
  • Parent or legal representative provides free and informed written consent
Not Eligible

You will not qualify if you...

  • Antenatal diagnosis of a pathology that could cause developmental delay
  • Presence of a congenital pathology revealed at birth, including metabolic, genetic, or malformative origins
  • Receiving palliative care with limitation or discontinuation of active treatments
  • Currently participating in another screening and early care program (except the COCON program)

AI-Screening

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Trial Site Locations

Total: 8 locations

1

CH de Annecy

Annecy, France, 74370

Actively Recruiting

2

Service de Réanimation et médecine néonatale

Chambéry, France, 73011

Actively Recruiting

3

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

Lyon, France, 69317

Actively Recruiting

4

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

Lyon, France, 69677

Actively Recruiting

5

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

Montpellier, France, 34295

Actively Recruiting

6

Service de néonatologie et de réanimation néonatale, Hôpital Universitaire Carémeau

Nîmes, France, 30029

Actively Recruiting

7

Service de réanimation pédiatrique, Hôpital des enfants

Toulouse, France, 31059

Actively Recruiting

8

Service de néonatologie, Hôpital des enfants

Toulouse, France, 31300

Actively Recruiting

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Research Team

V

Virginie MOURON, MD

CONTACT

J

Julie HAESEBAERT, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

SCREENING

Number of Arms

2

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