- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Nancy, Frankrig, 54001
- M.S.H. Lorraine/Lorraine Institue for Social Sciences and Humanities (CNRS, Université de Lorraine)
-
Nancy, Frankrig, 54035
- Maternite Regionale Univesitaire
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Ingen indgriben: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Cognitive and executive functions at school age in prematurely born children
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Quality of parent and children relationship
Tidsramme: 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)
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Utilization of care resources
Tidsramme: 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)
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Jean-Michel HASCOET, MD, Maternite Regionale Universitaire CHU NANCY
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MRU.10.11
- NEORIS (Anden identifikator: Maternite Regionale Universitaire)
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