NEORIS: Prematurity Related Risks of Cognitive Impairment at School Age

Sponsor

Jean Michel Hascoet (Other)

Overall Status

Completed

CT.gov ID

NCT02054507

Collaborator

Maternite Regionale Universitaire (Other)

100

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

2.2

Patients Per Site Per Month

Study Details

Study Description

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:

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.
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.
An anthropologic study of the utilization of care resources will also be performed within the follow-up network taking care of these children.

Condition or Disease	Intervention/Treatment	Phase
Complications of Prematurity	Behavioral: Cognitive evaluation (Wechsler IV tests)	N/A

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:

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.
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.
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.

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Apr 1, 2013

Actual Primary Completion Date :

Jul 1, 2014

Actual Study Completion Date :

Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Former premature infants Cognitive and executive evaluation by Wechsler IV tests	Behavioral: 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.

Arm

Intervention/Treatment

No Intervention: Former premature infants

Cognitive and executive evaluation by Wechsler IV tests

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

Cognitive and executive functions at school age in prematurely born children [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 Outcome Measures

Quality of parent and children relationship [Evaluated at 8-11 years of children (at the time of child cognitive evaluation)]
Evaluation will be performed by standardized questionnaire (Perinatal PTSD Questionnaire). This questionnaire allows evaluating persistent perinatal stress trauma related to prematurity.

Other Outcome Measures

Utilization of care resources [Evaluation of care network up to 18 months (within the time for children cognitive evaluation)]
anthropologic study of care and utilization of care resources using semi-directive interviews of caregivers involved in the follow-up network

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 11 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	M.S.H. Lorraine/Lorraine Institue for Social Sciences and Humanities (CNRS, Université de Lorraine)	Nancy		France	54001
2	Maternite Regionale Univesitaire	Nancy		France	54035