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Completed

NCT Number: NCT02054507

Prematurity Related Risks of Cognitive Impairment at School Age

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.

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Key information

Conditions

Complications of Prematurity Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

8 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive evaluation (Wechsler IV tests)

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.

Primary outcomes

  1. 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

  1. Quality of parent and children relationship

    Time frame: 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 outcomes

  1. Utilization of care resources

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Jean Michel Hascoet

Other

Collaborators

  • Maternite Regionale Universitaire

Registry information

Official study title

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

Acronym: NEORIS

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Feb 4, 2014
Registry last updated
Apr 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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