Cerebral PalsyPRECOPNCT06180291
EARLY Intervention in Parent-professional Cooperation in Cerebral Palsy
A study testing PRECOP program in people with Cerebral Palsy, run by Hospices Civils de Lyon at 8 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 3 months
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- PRECOP program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 8 sitesFrance
- Study dates
- 14 Mar 2025to 14 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 10Show fewer
- 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)
Who cannot join
- 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))
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
France8 sites, 8 recruiting
- Recruiting
CH de Annecy
Annecy, 74370
Alexandra BOWER DANLOS, MD, 04 50 63 63 24 ext. +33, abower@ch-annecygenevois.fr
- Recruiting
Service de Réanimation et médecine néonatale
Chambéry, 73011
Nathalie BOUCHON-GUEDJ, MD, 04 79 96 51 50 ext. +33, nathalie.bouchon-guedj@ch-metropole-savoie.fr
- Recruiting
Service de Réanimation Néonatale, Hôpital de la Croix-Rousse, Hospices Civils de Lyon
Lyon, 69317
Virginie MOURON, MD, 04 72 00 41 56 ext. +33, virginie.mouron@chu-lyon.fr
- Recruiting
Service de néonatologie et de réanimation néonatale, Hôpital Femme Mère Enfant, Hospices Civils de Lyon
Lyon, 69677
Kim N'GUYEN, MD, 04 27 85 52 84 ext. +33, huu-kim-an.nguyen@chu-lyon.fr
- Recruiting
Service de néonatologie et de réanimation néonatale, CHU Saint-ELOI
Montpellier, 34295
Odile PLAN, MD, 04 67 33 66 09 ext. +33, o-plan@chu-montpellier.fr
- Recruiting
Service de néonatologie et de réanimation néonatale, Hôpital Universitaire Carémeau
Nîmes, 30029
Isabelle SOUSKI, MD, 04 66 68 33 05 ext. +33, i.souski@perinatalite-occitanie.fr
- Recruiting
Service de réanimation pédiatrique, Hôpital des enfants
Toulouse, 31059
Sophie BREINIG, MD, 05 34 55 84 77 ext. +33, breinig.s@chu-toulouse.fr
- Recruiting
Service de néonatologie, Hôpital des enfants
Toulouse, 31300
Nathalie MONTJAUX, MD, 05 34 55 84 75 ext. +33, montjaux.n@chu-toulouse.fr
About this study
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.
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
- Cerebral Palsy
- Being tested
- PRECOP program
- Keywords
- early intervention program, functional impact, cerebral palsy, children
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRECOP programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | PRECOP group: screening and early treatment. CAMSP (Centre d'Action Médico-Sociale Précoce) orientation upon discharge from neonatology for immediate follow-up according to PRECOP protocol: early multidisciplinary care, with targeted objectives according to the child's needs. Receives: Other: PRECOP program |
| Control group | No intervention | Standard of care group: in the control centers, care includes specialized consultations organized by the perinatal network with a hospital and/or community pediatrician belonging to the network until the child is 2 years old. Cerebral palsy screening is based on clinical examination. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of the Total Motor Index at PDMS-3 scale (Peabody Developmental Motor Scales).
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.
Measured: 24 months
Secondary outcomes (14)
Motor development
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.
Measured: 24 months
Cognitive development
Cognitive development will be measured by the Ages and Stages Questionnaire (ASQ)
Measured: 24 months
Nutritional development
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.
Measured: 24 months
Development of Production Language in French (DLPF) questionnaire
The development of communication and language will be assessed through the Development of Production Language in French (DLPF) questionnaire
Measured: 24 months
Early relational problems
Early relational problems will be detected by Modified Checklist for Autism in Toddlers (M CHAT)
Measured: 24 months
Parental stress
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.
Measured: 24 months
Implemented intervention and fidelity to the planned intervention at the center level
Number of professionals trained and profile of professionals, human, material and organizational resources mobilized.
Measured: through study completion, an average of 42 months
Intervention implemented and fidelity to the planned intervention at the patient level
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.
Measured: through study completion, an average of 42 months
Parental adherence
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.
Measured: through study completion, an average of 42 months
Acceptability of the intervention
Acceptability from the parents' and professionals point of view, assessed by a questionnaire constructed for the study.
Measured: through study completion, an average of 42 months
Program transferability using PIET model: Population, Intervention, Environment, Transfer
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.
Measured: through study completion, an average of 42 months
Cost ratio impact
Differential cost ratio resulting from the PRECOP strategy compared to the management of the control group.
Measured: 12, 24 and 36 months
Annual cost impact
Average annual cost of support for the financier depending on the pricing methods.
Measured: 12, 24 and 36 months
Budgetary impact
Estimating annual net budget up to 3 years according to trial data, literature and expert opinion.
Measured: 12, 24 and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2023
- Study start14 Mar 2025
- Primary completion14 Sep 2029 (estimated)
- Study completion14 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective multicenter comparative non-randomized study evaluating the effectiveness of a new management strategy for children at high risk of cerebral palsy compared to the management of the control group. The research will take place in 8 centers, 4 centers offering early intervention (Lyon Croix-Rousse, Lyon Hôpital Femme-Mère-Enfant, Montpellier, Nîmes), and 4 centers not offering standardized early intervention (Toulouse neonatal care unit, Toulouse pediatric intensive care unit, Chambéry and Annecy). The control centers were recruited on the basis of common characteristics of neonatology level of care and active queue. Each center will consecutively include newborns during the neonatology stay. The study will compare the intervention group composed of children cared for in intervention centers to the control group composed of children cared for in control centers.
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Virginie MOURON, MD, Principal investigator, Service de Réanimation Néonatale, Hôpital de la Croix-Rousse, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06180291
- Sponsor's protocol ID
- 69HCL22_0862
- Acronym
- PRECOP
- Status last verified
- Apr 2026
- First submitted
- 23 Oct 2023
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06180291
- Acronym / sponsor ID
- PRECOP / 69HCL22_0862
- Conditions
- Cerebral Palsy
- Keywords
- early intervention program, functional impact, cerebral palsy, children
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 14 Mar 2025 (actual)
- Primary completion
- 14 Sep 2029 (estimated)
- Study completion
- 14 Sep 2029 (estimated)
- First posted
- 22 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective multicenter comparative non-randomized study evaluating the effectiveness of a new management strategy for children at high risk of cerebral palsy compared to the management of the control group. The research will take place in 8 centers, 4 centers offering early intervention (Lyon Croix-Rousse, Lyon Hôpital Femme-Mère-Enfant, Montpellier, Nîmes), and 4 centers not offering standardized early intervention (Toulouse neonatal care unit, Toulouse pediatric intensive care unit, Chambéry and Annecy). The control centers were recruited on the basis of common characteristics of neonatology level of care and active queue. Each center will consecutively include newborns during the neonatology stay. The study will compare the intervention group composed of children cared for in intervention centers to the control group composed of children cared for in control centers.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: PRECOP programPRECOP group: screening and early treatment. CAMSP (Centre d'Action Médico-Sociale Précoce) orientation upon discharge from neonatology for immediate follow-up according to PRECOP protocol: early multidisciplinary care, with targeted objectives according to the child's needs. |
| Control group | No intervention | –Standard of care group: in the control centers, care includes specialized consultations organized by the perinatal network with a hospital and/or community pediatrician belonging to the network until the child is 2 years old. Cerebral palsy screening is based on clinical examination. |
Who may qualify
- Ages
- Up to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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 :
- 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)
Key exclusion criteria (4 listed)
- 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))
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRECOP programPRECOP 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. | Other | Intervention group |
Primary outcome
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.
14 secondary outcomes
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
Annual cost impact
Time frame: 12, 24 and 36 months
Budgetary impact
Time frame: 12, 24 and 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Virginie MOURON, MD principal investigator
Service de Réanimation Néonatale, Hôpital de la Croix-Rousse, Hospices Civils de Lyon
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRECOP program in people with Cerebral Palsy, run by Hospices Civils de Lyon at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Virginie MOURON, MD (0472004156 ext. +33, Virginie.mouron@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of the Total Motor Index at PDMS-3 scale (Peabody Developmental Motor Scales). (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.