Clinical Trials Directory

Trials / Completed

CompletedNCT02054507

Prematurity Related Risks of Cognitive Impairment at School Age

Prematurity Related Risks of Cognitive Impairment at School Age With Regards to Social, Family and Care Environment

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
100 (actual)
Sponsor
Jean Michel Hascoet · Academic / Other
Sex
All
Age
8 Years – 11 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALCognitive 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.

Timeline

Start date
2013-04-01
Primary completion
2014-07-01
Completion
2015-03-01
First posted
2014-02-04
Last updated
2015-04-08

Locations

2 sites across 1 country: France

Source: ClinicalTrials.gov record NCT02054507. Inclusion in this directory is not an endorsement.