Long-term Neurodevelopmental Disorders of Prematurely Born Children and Parental Experience
NCT ID: NCT04607109
Last Updated: 2022-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
238 participants
OBSERVATIONAL
2020-11-02
2021-07-31
Brief Summary
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In 2011, the Epipage 2 study showed a significant improvement as compared with the 1997 Epipage1 study with a decrease in mortality and an increase of the survival rate without severe morbidity of 14% for preterm babies born between 25 and 29 weeks and 6% for babies born between 30 and 31 weeks.
However, surviving babies without initial major deficiencies, may later show problems in terms of growth, sensory - motor and/or neuro-psychologic development. This untoward evolution lead to social and family interaction disorders and school difficulties.
In this context, a perinatal care network was created for each Region in France, making it possible to take care of these vulnerable children early on and all along their development. A retrospective study will evaluate 97 pre-term babies born before 33 weeks in 2012 and who are taken care of at Nancy as part of the Lorraine regional network program "Rafael" until they are 7 years old.
The objective is to evaluate objectively the neurocognitive and school abilities of these children at the age of 7.
At 8 years of age, a secondary measure of outcome will be the impact of the eventual neurocognitive consequences on the quality of their family life, on the behavior of the child and the parents' feelings. This way more options to improve the way they are taken care of will be available.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* and involved in the Lorraine Perinatal Follow-up program at 7 years old
Exclusion Criteria
7 Years
8 Years
ALL
No
Sponsors
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Central Hospital, Nancy, France
OTHER
Responsible Party
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Jean-Michel HASCOET
Professor
Locations
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Maternity Hospital CHRU
Nancy, , France
Countries
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Other Identifiers
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2020PI166
Identifier Type: -
Identifier Source: org_study_id
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