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Clinical Trials/NCT02054507
NCT02054507
Completed
N/A

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

Jean Michel Hascoet2 sites in 1 country100 target enrollmentApril 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Complications of Prematurity
Sponsor
Jean Michel Hascoet
Enrollment
100
Locations
2
Primary Endpoint
Cognitive and executive functions at school age in prematurely born children
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2013
End Date
March 2015
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Jean Michel Hascoet
Responsible Party
Sponsor Investigator
Principal Investigator

Jean Michel Hascoet

Professor

Maternite Regionale Universitaire

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

Outcomes

Primary Outcomes

Cognitive and executive functions at school age in prematurely born children

Time Frame: Children at the age of 8-11 years

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 Outcomes

  • Quality of parent and children relationship(Evaluated at 8-11 years of children (at the time of child cognitive evaluation))

Study Sites (2)

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