Prematurity Related Risks of Cognitive Impairment at School Age
NCT ID: NCT02054507
Last Updated: 2015-04-08
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
100 participants
INTERVENTIONAL
2013-04-30
2015-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The study will be divided into 3 parts:
1. 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.
2. 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.
3. An anthropologic study of the utilization of care resources will also be performed within the follow-up network taking care of these children.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of Brain Plasticity in Premature Infants at School Age After Cognitive Remediation
NCT03972761
Cerebral Magnetic Resonance Spectroscopy at Term Corrected Age and Dysexecutive Syndrome in Very Preterm Children at 5.5-years-old
NCT06055062
Associations Between General Movements Assessments and Cognitive Development
NCT05217056
Brainstem and Prematurity
NCT02669056
Cerebral Abnormalities Detected by MRI, Realized at the Age of Term and the Emergence of Executive Functions
NCT02083822
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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:
1. 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.
2. 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.
3. 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Former premature infants
Cognitive and executive evaluation by Wechsler IV tests
Cognitive evaluation (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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cognitive evaluation (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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* School grade appropriate for their age
* Schoolmate control children born at term aged 8-11 years
Exclusion Criteria
8 Years
11 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Maternite Regionale Universitaire
OTHER
Jean Michel Hascoet
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jean Michel Hascoet
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jean-Michel HASCOET, MD
Role: PRINCIPAL_INVESTIGATOR
Maternite Regionale Universitaire CHU NANCY
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
M.S.H. Lorraine/Lorraine Institue for Social Sciences and Humanities (CNRS, Université de Lorraine)
Nancy, , France
Maternite Regionale Univesitaire
Nancy, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NEORIS
Identifier Type: OTHER
Identifier Source: secondary_id
MRU.10.11
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.