ट्रायल रडार AI | ||
|---|---|---|
क्लिनिकल ट्रायल NCT06180291 (PRECOP) के लिए मस्तिष्क पक्षाघात वर्तमान में भर्ती जारी है। सभी विवरणों के लिए क्लिनिकल ट्रायल रडार कार्ड दृश्य और AI खोज उपकरण देखें, या यहाँ कुछ भी पूछें। | ||
एक परीक्षण फ़िल्टर मानदंडों से मेल खाता है
कार्ड दृश्य
EARLY Intervention in Parent-professional Cooperation in Cerebral Palsy (PRECOP) 66 घर पर अंतर्राष्ट्रीय
चिकित्सा परीक्षण का विवरण मुख्य रूप से अंग्रेजी में उपलब्ध है। हालाँकि, ट्रायल रडार AI मदद कर सकता है! बस 'अध्ययन समझाएं' पर क्लिक करें और अपनी चुनी हुई भाषा में परीक्षण की जानकारी देखें और चर्चा करें।
क्लिनिकल ट्रायल NCT06180291 (PRECOP) एक हस्तक्रियात्मक चिकित्सकीय अध्ययन है जो मस्तिष्क पक्षाघात से जुड़ा हुआ है। परीक्षण वर्तमान में भर्ती जारी चल रहा है। इसकी शुरुआत 14 मार्च 2025 को हुई थी, और इसमें कुल 66 प्रतिभागियों के नामांकन की योजना है। Hospices Civils de Lyon इस परीक्षण का नेतृत्व कर रहे हैं और इसके 1 अक्तूबर 2028 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 6 अप्रैल 2025 को अंतिम बार अपडेट की गई थी।
संक्षिप्त सारांश
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 ...और दिखाएँ
आधिकारिक शीर्षक
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.
स्वास्थ्य स्थितियां
मस्तिष्क पक्षाघातअन्य अध्ययन आईडी
- PRECOP
- 69HCL22_0862
NCT नंबर
अध्ययन प्रारंभ तिथि (वास्तविक)
2025-03-14
अंतिम अद्यतन प्रकाशित
2025-04-06
अध्ययन की समाप्ति तिथि (अनुमानित)
2028-10-01
नामांकन (अनुमानित)
66
अध्ययन प्रकार
हस्तक्रियात्मक
चरण
निर्दिष्ट नहीं
स्थिति
भर्ती जारी
प्रमुख शब्द
early intervention program
functional impact
cerebral palsy
children
functional impact
cerebral palsy
children
प्राथमिक उद्देश्य
जाँच (स्क्रीनिंग)
डिज़ाइन आवंटन
गैर-यादृच्छिक
हस्तक्षेप मॉडल
समानांतर
अंधकरण
कोई नहीं (खुला लेबल)
समूह/हस्तक्षेप
| प्रतिभागी समूह/शाखा | हस्तक्षेप/उपचार |
|---|---|
प्रयोगात्मकIntervention 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 ...और दिखाएँ |
कोई हस्तक्षेप नहींControl 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. | निर्दिष्ट नहीं |
प्राथमिक परिणाम माप
द्वितीयक परिणाम माप
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
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 |
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
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 |
भागीदारी सहायक
पात्रता मानदंड
अध्ययन के लिए पात्र आयु
बच्चा
अध्ययन के लिए पात्र लिंग
सभी
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 Lyonअध्ययन केंद्रीय संपर्क
संपर्क: Virginie MOURON, MD, 0472004156, [email protected]
संपर्क: Julie HAESEBAERT, PhD, 0472115165, [email protected]
8 1 देशों में अध्ययन स्थान
CH de Annecy, Annecy, 74370, France
Alexandra BOWER DANLOS, MD, संपर्क, 04 50 63 63 24, [email protected]
अभी भर्ती शुरू नहीं
Service de Réanimation et médecine néonatale, Chambéry, 73011, France
Nathalie BOUCHON-GUEDJ, MD, संपर्क, 04 79 96 51 50, [email protected]
अभी भर्ती शुरू नहीं
Service de Réanimation Néonatale, Hôpital de la Croix-Rousse, Hospices Civils de Lyon, Lyon, 69317, France
Virginie MOURON, MD, संपर्क, 04 72 00 41 56, [email protected]
भर्ती जारी
Service de néonatologie et de réanimation néonatale, Hôpital Femme Mère Enfant, Hospices Civils de Lyon, Lyon, 69677, France
Kim N'GUYEN, MD, संपर्क, 04 27 85 52 84, [email protected]
अभी भर्ती शुरू नहीं
Service de néonatologie et de réanimation néonatale, CHU Saint-ELOI, Montpellier, 34295, France
Odile PLAN, MD, संपर्क, 04 67 33 66 09, [email protected]
अभी भर्ती शुरू नहीं
Service de néonatologie et de réanimation néonatale, Hôpital Universitaire Carémeau, Nîmes, 30029, France
Isabelle SOUSKI, MD, संपर्क, 04 66 68 33 05, [email protected]
अभी भर्ती शुरू नहीं
Service de réanimation pédiatrique, Hôpital des enfants, Toulouse, 31059, France
Sophie BREINIG, MD, संपर्क, 05 34 55 84 77, [email protected]
अभी भर्ती शुरू नहीं
Service de néonatologie, Hôpital des enfants, Toulouse, 31300, France
Nathalie MONTJAUX, MD, संपर्क, 05 34 55 84 75, [email protected]
अभी भर्ती शुरू नहीं