Prematurity Related Risks of Cognitive Impairment at School Age

NCT ID: NCT02054507

Last Updated: 2015-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-03-31

Brief Summary

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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

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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

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Complications of Prematurity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Former premature infants

Cognitive and executive evaluation by Wechsler IV tests

Group Type NO_INTERVENTION

Cognitive evaluation (Wechsler IV tests)

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Maternite Regionale Universitaire

OTHER

Sponsor Role collaborator

Jean Michel Hascoet

OTHER

Sponsor Role lead

Responsible Party

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Jean Michel Hascoet

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jean-Michel HASCOET, MD

Role: PRINCIPAL_INVESTIGATOR

Maternite Regionale Universitaire CHU NANCY

Locations

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M.S.H. Lorraine/Lorraine Institue for Social Sciences and Humanities (CNRS, Université de Lorraine)

Nancy, , France

Site Status

Maternite Regionale Univesitaire

Nancy, , France

Site Status

Countries

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France

Other Identifiers

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NEORIS

Identifier Type: OTHER

Identifier Source: secondary_id

MRU.10.11

Identifier Type: -

Identifier Source: org_study_id

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