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临床试验 NCT06180291 (PRECOP) 针对脑瘫目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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EARLY Intervention in Parent-professional Cooperation in Cerebral Palsy (PRECOP) 66 居家 国际
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临床试验NCT06180291 (PRECOP)是一项针对脑瘫的干预性研究试验，目前试验状态为招募中。试验始于2025年3月14日，计划招募66名患者。该研究由Hospices Civils de Lyon主导，预计于2028年10月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年4月6日。
简要概括
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 ...显示更多
官方标题
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.
疾病
脑瘫其他研究标识符
- PRECOP
- 69HCL22_0862
NCT编号
实际开始日期
2025-03-14
最近更新发布
2025-04-06
预计完成日期
2028-10-01
计划入组人数
66
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
招募中
关键词
early intervention program
functional impact
cerebral palsy
children
functional impact
cerebral palsy
children
主要目的
筛查
分配方式
非随机
干预模型
平行
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性Intervention group 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. | 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 ...显示更多 |
无干预Control group 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. | 不适用 |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
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. | 24 months |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
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. | 24 months |
Cognitive development | Cognitive development will be measured by the Ages and Stages Questionnaire (ASQ) | 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. | 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 | 24 months |
Early relational problems | Early relational problems will be detected by Modified Checklist for Autism in Toddlers (M CHAT) | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 12, 24 and 36 months |
Annual cost impact | Average annual cost of support for the financier depending on the pricing methods. | 12, 24 and 36 months |
Budgetary impact | Estimating annual net budget up to 3 years according to trial data, literature and expert opinion. | 12, 24 and 36 months |
参与助手
资格标准
适龄参与研究
儿童
适龄性别
全部
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)
- 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))
Hospices Civils de Lyon研究中心联系人
联系人: Virginie MOURON, MD, 0472004156, [email protected]
联系人: Julie HAESEBAERT, PhD, 0472115165, [email protected]
8 位于 1 个国家/地区的研究中心
CH de Annecy, Annecy, 74370, France
Alexandra BOWER DANLOS, MD, 联系人, 04 50 63 63 24, [email protected]
尚未招募
Service de Réanimation et médecine néonatale, Chambéry, 73011, France
Nathalie BOUCHON-GUEDJ, MD, 联系人, 04 79 96 51 50, [email protected]
尚未招募
Service de Réanimation Néonatale, Hôpital de la Croix-Rousse, Hospices Civils de Lyon, Lyon, 69317, France
Virginie MOURON, MD, 联系人, 04 72 00 41 56, [email protected]
招募中
Service de néonatologie et de réanimation néonatale, Hôpital Femme Mère Enfant, Hospices Civils de Lyon, Lyon, 69677, France
Kim N'GUYEN, MD, 联系人, 04 27 85 52 84, [email protected]
尚未招募
Service de néonatologie et de réanimation néonatale, CHU Saint-ELOI, Montpellier, 34295, France
Odile PLAN, MD, 联系人, 04 67 33 66 09, [email protected]
尚未招募
Service de néonatologie et de réanimation néonatale, Hôpital Universitaire Carémeau, Nîmes, 30029, France
Isabelle SOUSKI, MD, 联系人, 04 66 68 33 05, [email protected]
尚未招募
Service de réanimation pédiatrique, Hôpital des enfants, Toulouse, 31059, France
Sophie BREINIG, MD, 联系人, 05 34 55 84 77, [email protected]
尚未招募
Service de néonatologie, Hôpital des enfants, Toulouse, 31300, France
Nathalie MONTJAUX, MD, 联系人, 05 34 55 84 75, [email protected]
尚未招募