- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio 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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
-
Nancy, França, 54001
- M.S.H. Lorraine/Lorraine Institue for Social Sciences and Humanities (CNRS, Université de Lorraine)
-
Nancy, França, 54035
- Maternite Regionale Univesitaire
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Diagnóstico
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Sem intervenção: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Cognitive and executive functions at school age in prematurely born children
Prazo: Children at the age of 8-11 years
|
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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Quality of parent and children relationship
Prazo: Evaluated at 8-11 years of children (at the time of child cognitive evaluation)
|
Evaluation will be performed by standardized questionnaire (Perinatal PTSD Questionnaire).
This questionnaire allows evaluating persistent perinatal stress trauma related to prematurity.
|
Evaluated at 8-11 years of children (at the time of child cognitive evaluation)
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Utilization of care resources
Prazo: Evaluation of care network up to 18 months (within the time for children cognitive evaluation)
|
anthropologic study of care and utilization of care resources using semi-directive interviews of caregivers involved in the follow-up network
|
Evaluation of care network up to 18 months (within the time for children cognitive evaluation)
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Jean-Michel HASCOET, MD, Maternite Regionale Universitaire CHU NANCY
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- MRU.10.11
- NEORIS (Outro identificador: Maternite Regionale Universitaire)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .