Clinical trial NCT02054507: Prematurity Related Risks of Cognitive Impairment at School Age
Official title: Prematurity Related Risks of Cognitive Impairment at School Age With Regards to Social, Family and Care Environment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complications of Prematurity
Keywords: Children
Cognitive outcome
Prematurity
Care Network
Outpatient follow-up of cognitive development
Care resources
Lead sponsor: Maternite Regionale Universitaire
Sponsor class: OTHER
Collaborators: name: Maternite Regionale Universitaire
First posted: 2014-02-04
Enrollment: 100
Sex: ALL
Minimum age (years): 8
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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:

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.

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:

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.

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

Primary outcomes:
measure: Cognitive and executive functions at school age in prematurely born children
timeFrame: Children at the age of 8-11 years
Secondary outcomes:
measure: Quality of parent and children relationship
timeFrame: Evaluated at 8-11 years of children (at the time of child cognitive evaluation)
Other outcomes:
measure: Utilization of care resources
timeFrame: Evaluation of care network up to 18 months (within the time for children cognitive evaluation)
Locations:
city: Nancy
country: France
facility: M.S.H. Lorraine/Lorraine Institue for Social Sciences and Humanities (CNRS, Université de Lorraine)
city: Nancy
country: France
facility: Maternite Regionale Univesitaire
Study officials:
affiliation: Maternite Regionale Universitaire CHU NANCY
name: Jean-Michel HASCOET, MD
role: PRINCIPAL_INVESTIGATOR
References: