Cerebral Abnormalities Detected by MRI, Realized at the Age of Term and the Emergence of Executive Functions (EPIRMEX)
The survival of premature babies increased during the last decades. However, the neurocognitive long term development of these children is worrying, as demonstrated by EPIPAGE 1 study.
These children present high risk of deficits such as cognitive deficits, adaptive malfunction, behavior disorders and difficulties in school learning.
Understanding the specific neuropsychological disorders at the origin of these deficits is an important objective. Studies realized at school age showed that many premature children have executive functions (EF) disorders. However the specific nature of these disorders and the neuropathology associated are unknown.
The aim of this study is to realise MRI at term age in preterm babies born less than 32 GA and to correlate MRI findings with executives functions and neurodevelopmental outcome
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
An MRI would be realized between 39 and 41 GA
At the age of 5 years, executive functions and neurodevelopmental testing would be realized.
600 newborns were recruited.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
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Angers, Frankrig, 49 000
- Service de Neurologie Pédiatrique
-
Bordeaux, Frankrig, 33 000
- Service de Néonatologie
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Caen, Frankrig, 14 000
- Service de Néonatologie
-
Grenoble, Frankrig, 38 000
- Médecine Néonatale et Réanimation Pédiatrique
-
Le Kremlin-Bicêtre, Frankrig, 94275
- Service de REANIMATION NEONATALE ET PEDIATRIQUE, NEONATOLOGIE
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Lille, Frankrig, 59 000
- Service de Néonatologie
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Marseille, Frankrig, 13 000
- Médecine Infantile - Néonatologie - Périnatologie
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Marseille, Frankrig, 13 000
- Service de Néonatalogie
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Nancy, Frankrig, 54000
- Service de Néonatologie
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Nantes, Frankrig, 44000
- Service de Néonatologie
-
Paris, Frankrig, 75 000
- Réanimation néonatale et Néonatologie
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Reims, Frankrig, 51 000
- Service de Réanimation, Néonatologie
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Rennes, Frankrig, 35000
- Service de Néonatologie
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Rouen, Frankrig, 76000
- Service de Pédiatrie Néonatale et Réanimation
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Tours, Frankrig, 37 000
- Service de Réanimation pédiatrique, Néonatologie
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria
Infants who were :
- born between 25 and 32 WGA
- hospitalized in a neonatology service which participate to the present study
- included in EPIPAGE 2 follow-up study
- infants whose parents had signed the consent agreement and benefit from national health insurance
Exclusion Criteria
- Infants with congenital abnormalities
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 |
|---|---|
|
Eksperimentel: MRI assessment
|
An MRI will be realized at term born between 25 and 32 weeks GA
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Executive functions evaluation at age of 5 and comparison with conventionnal and advanced MRI imagings
Tidsramme: During the 5 years follow up
|
During the 5 years follow up
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Perinatal risk factors and cerebral lesions as assessed on MRI
Tidsramme: During the 5 years follow up
|
During the 5 years follow up
|
|
Perinatal risk factors and executive and cognitive functions evaluated at 5 years of age
Tidsramme: During the 5 years follow up
|
During the 5 years follow up
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Anslået)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PHRN11-ES / EPIRMEX
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