Prematurity Related Risks of Cognitive Impairment at School Age (NEORIS)
Primary Purpose
Complications of Prematurity
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cognitive evaluation (Wechsler IV tests)
Sponsored by
About this trial
This is an interventional diagnostic trial for Complications of Prematurity focused on measuring Children, Cognitive outcome, Prematurity, Care Network, Outpatient follow-up of cognitive development, Care resources
Eligibility Criteria
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
Sites / Locations
- M.S.H. Lorraine/Lorraine Institue for Social Sciences and Humanities (CNRS, Université de Lorraine)
- Maternite Regionale Univesitaire
Arms of the Study
Arm 1
Arm Type
No Intervention
Arm Label
Former premature infants
Arm Description
Cognitive and executive evaluation by Wechsler IV tests
Outcomes
Primary Outcome Measures
Cognitive and executive functions at school age in prematurely born children
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.
Secondary Outcome Measures
Quality of parent and children relationship
Evaluation will be performed by standardized questionnaire (Perinatal PTSD Questionnaire). This questionnaire allows evaluating persistent perinatal stress trauma related to prematurity.
Full Information
NCT ID
NCT02054507
First Posted
January 27, 2014
Last Updated
April 7, 2015
Sponsor
Jean Michel Hascoet
Collaborators
Maternite Regionale Universitaire
1. Study Identification
Unique Protocol Identification Number
NCT02054507
Brief Title
Prematurity Related Risks of Cognitive Impairment at School Age
Acronym
NEORIS
Official Title
Prematurity Related Risks of Cognitive Impairment at School Age With Regards to Social, Family and Care Environment
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jean Michel Hascoet
Collaborators
Maternite Regionale Universitaire
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complications of Prematurity
Keywords
Children, Cognitive outcome, Prematurity, Care Network, Outpatient follow-up of cognitive development, Care resources
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Former premature infants
Arm Type
No Intervention
Arm Description
Cognitive and executive evaluation by Wechsler IV tests
Intervention Type
Behavioral
Intervention Name(s)
Cognitive evaluation (Wechsler IV tests)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cognitive and executive functions at school age in prematurely born children
Description
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.
Time Frame
Children at the age of 8-11 years
Secondary Outcome Measure Information:
Title
Quality of parent and children relationship
Description
Evaluation will be performed by standardized questionnaire (Perinatal PTSD Questionnaire). This questionnaire allows evaluating persistent perinatal stress trauma related to prematurity.
Time Frame
Evaluated at 8-11 years of children (at the time of child cognitive evaluation)
Other Pre-specified Outcome Measures:
Title
Utilization of care resources
Description
anthropologic study of care and utilization of care resources using semi-directive interviews of caregivers involved in the follow-up network
Time Frame
Evaluation of care network up to 18 months (within the time for children cognitive evaluation)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Michel HASCOET, MD
Organizational Affiliation
Maternite Regionale Universitaire CHU NANCY
Official's Role
Principal Investigator
Facility Information:
Facility Name
M.S.H. Lorraine/Lorraine Institue for Social Sciences and Humanities (CNRS, Université de Lorraine)
City
Nancy
ZIP/Postal Code
54001
Country
France
Facility Name
Maternite Regionale Univesitaire
City
Nancy
ZIP/Postal Code
54035
Country
France
12. IPD Sharing Statement
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Prematurity Related Risks of Cognitive Impairment at School Age
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