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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02054507
Acronym
NEORIS
Enrollment
100
Registered
2014-02-04
Start date
2013-04-30
Completion date
2015-03-31
Last updated
2015-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complications of Prematurity

Keywords

Children, Cognitive outcome, Prematurity, Care Network, Outpatient follow-up of cognitive development, Care resources

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.

Interventions

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.

Sponsors

Maternite Regionale Universitaire
CollaboratorOTHER
Jean Michel Hascoet
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
8 Years to 11 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Cognitive and executive functions at school age in prematurely born childrenChildren at the age of 8-11 yearsAssessment 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

MeasureTime frameDescription
Quality of parent and children relationshipEvaluated 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

MeasureTime frameDescription
Utilization of care resourcesEvaluation 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026