Complications of Prematurity Clinical Trial
Official title:
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:
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.
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:
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.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02147769 -
Cerebral Oxygenation and Autoregulation in Preterm Infants
|