- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Nancy, France, 54001
- M.S.H. Lorraine/Lorraine Institue for Social Sciences and Humanities (CNRS, Université de Lorraine)
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Nancy, France, 54035
- Maternite Regionale Univesitaire
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive and executive functions at school age in prematurely born children
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of parent and children relationship
Time Frame: 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)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Utilization of care resources
Time Frame: 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)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jean-Michel HASCOET, MD, Maternite Regionale Universitaire CHU NANCY
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MRU.10.11
- NEORIS (Other Identifier: Maternite Regionale Universitaire)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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