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Prematurity Related Risks of Cognitive Impairment at School Age (NEORIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02054507
Recruitment Status : Completed
First Posted : February 4, 2014
Last Update Posted : April 8, 2015
Sponsor:
Collaborator:
Maternite Regionale Universitaire
Information provided by (Responsible Party):
Jean Michel Hascoet, Maternite Regionale Universitaire

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.

Condition or disease Intervention/treatment Phase
Complications of Prematurity Behavioral: Cognitive evaluation (Wechsler IV tests) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
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 : April 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : March 2015

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02054507


Locations
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France
M.S.H. Lorraine/Lorraine Institue for Social Sciences and Humanities (CNRS, Université de Lorraine)
Nancy, France, 54001
Maternite Regionale Univesitaire
Nancy, France, 54035
Sponsors and Collaborators
Jean Michel Hascoet
Maternite Regionale Universitaire
Investigators
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Principal Investigator: Jean-Michel HASCOET, MD Maternite Regionale Universitaire CHU NANCY

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Responsible Party: Jean Michel Hascoet, Professor, Maternite Regionale Universitaire
ClinicalTrials.gov Identifier: NCT02054507    
Other Study ID Numbers: MRU.10.11
NEORIS ( Other Identifier: Maternite Regionale Universitaire )
First Posted: February 4, 2014    Key Record Dates
Last Update Posted: April 8, 2015
Last Verified: April 2015
Keywords provided by Jean Michel Hascoet, Maternite Regionale Universitaire:
Children
Cognitive outcome
Prematurity
Care Network
Outpatient follow-up of cognitive development
Care resources
Additional relevant MeSH terms:
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Premature Birth
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications