- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02054507
Prematurity Related Risks of Cognitive Impairment at School Age (NEORIS)
Prematurity Related Risks of Cognitive Impairment at School Age With Regards to Social, Family and Care Environment
The main purpose of this study is to better evaluate prematurely born children cognitive development at school age, with regards to birth conditions but also to social situation, intra family relationships, and modalities of care.
The study will be divided into 3 parts:
- Children born prematurely in our level III referral Center will undergo psychometric evaluation at 8 to 11 years of age by routine cognitive test. The relationships between cognitive scores and neonatal characteristics will be determined and compared to the results of schoolmates born at term.
- The quality of parent and child relationship will be evaluated by a standardized questionnaire allowing the evaluation of persistent stress trauma related to premature birth.
- An anthropologic study of the utilization of care resources will also be performed within the follow-up network taking care of these children.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Long term follow-up of vulnerable children such as infants born prematurely are generally studied without taking into account the social, familial and care resources available in the child environment.
Thus, the main purpose of this study is to evaluate prematurely born children cognitive development at school age, with regards to birth conditions but also to related social situation, intra family relationships, modalities of care and utilization of care resources.
The study will be divided into 3 parts:
- Children born prematurely in our level III referral Center will undergo psychometric evaluation at 8 to 11 years of age by routine test (WISC IV). The relationship between cognitive scores and neonatal characteristics will be determined and compared with the results of schoolmate control children, born at term.
- The quality of parent and child relationship will be evaluated by standardized questionnaire (Perinatal PTSD Questionnaire). This questionnaire allows evaluating persistent perinatal stress trauma related to prematurity.
- An anthropologic study of care and utilization of care resources will be performed within the follow-up network taking care of these children. This part will use semi-directive interviews of caregivers involved in the follow-up network.
This study should allow to better correlate prematurely born children outcome with their global environment and propose improvements in care resources utilization for a better development.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Nancy, Francia, 54001
- M.S.H. Lorraine/Lorraine Institue for Social Sciences and Humanities (CNRS, Université de Lorraine)
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Nancy, Francia, 54035
- Maternite Regionale Univesitaire
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Former premature infants aged 8-11 years
- School grade appropriate for their age
- Schoolmate control children born at term aged 8-11 years
Exclusion Criteria:
- Any neurological sequelae
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Sin intervención: Former premature infants
Cognitive and executive evaluation by Wechsler IV tests
|
Children born prematurely in a level III referral Center will undergo psychometric evaluation at 8 to 11 years of age by routine test (WISC IV).
The relationship between cognitive scores and neonatal characteristics will be determined and compared with the results of schoolmate control children, born at term.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Cognitive and executive functions at school age in prematurely born children
Periodo de tiempo: Children at the age of 8-11 years
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Assessment by WECHSLER IV tests of children born prematurely without neurological or sensorial sequelae, and without psychological difficulties; All in school grade appropriate for their ages Controls : children born at term, matched for age and school grade. |
Children at the age of 8-11 years
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Quality of parent and children relationship
Periodo de tiempo: Evaluated at 8-11 years of children (at the time of child cognitive evaluation)
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Evaluation will be performed by standardized questionnaire (Perinatal PTSD Questionnaire).
This questionnaire allows evaluating persistent perinatal stress trauma related to prematurity.
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Evaluated at 8-11 years of children (at the time of child cognitive evaluation)
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Utilization of care resources
Periodo de tiempo: Evaluation of care network up to 18 months (within the time for children cognitive evaluation)
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anthropologic study of care and utilization of care resources using semi-directive interviews of caregivers involved in the follow-up network
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Evaluation of care network up to 18 months (within the time for children cognitive evaluation)
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Jean-Michel HASCOET, MD, Maternite Regionale Universitaire CHU NANCY
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- MRU.10.11
- NEORIS (Otro identificador: Maternite Regionale Universitaire)
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Ensayos clínicos sobre Cognitive evaluation (Wechsler IV tests)
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