Preterm Birth and Social Cognition (TERM-COG)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03007095
Recruitment Status : Recruiting
First Posted : January 2, 2017
Last Update Posted : February 13, 2018
Information provided by (Responsible Party):
CHU de Reims

Brief Summary:
The study aims at investigating social cognition outcomes of children born prematurely. Social cognition can be briefly defined as a process which underlines people's social and emotional behaviors. There are behavioral and cognitive evidences indicating that preterm children have executive dysfunctions. Executive functions refer to multiple cognitive processes that contribute to human higher order abilities, such as purposeful and future-orientated behavior. The literature regarding development of term born children indicates that executive functions are linked to the emergence of social cognition. Then, the investigators asked if children born prematurely, as they commonly present executive dysfunctions, would show an atypical development of social cognition. Additionally, as it has been shown that parental anxiety is a key factor of preterm children development, the investigators assumed that it should play a role in social cognition outcomes.

Condition or disease Intervention/treatment Phase
Preterm Children Behavioral: Evaluation of the children's social cognitive development Not Applicable

Detailed Description:

The present study examines the social cognition development of very preterm children at 7 to 10 years old. In the literature, there has yet to be any research on social cognition of children born prematurely while preterm children are usually described as having difficulties in social relations. The main hypothesis is that preterm children would present a deficit or a delay in the social cognition development in comparison with that of matched term children, and that this deficit or delay should be explained by executive dysfunctions and parental anxiety.

Social cognition can be defined as the ability to understand the mind of other people and more specifically to perceive emotion, to have empathy, to attribute false-belief, to understand intended meaning, among others. In this study, the investigators will mainly focus on the ability of 80 very preterm children to understand the mind of others, well known as theory of mind in the literature, thanks to small stories involving the thinking and feelings of characters.

The executive functioning, which refers to multiple processes underlying human higher order abilities, will be assessed thanks to standardized neuropsychological tests. In this study, the investigators will focus on the three main well known executive functions: inhibition, working memory and shifting. They expect, consistently with the literature, that preterm children will have executive dysfunctions, and that these will be linked to children theory of mind abilities.

Finally, given that parental anxiety affects child development, the investigators plan to assess some psychological features of children's parents in our study, such the level of parental anxiety. They assume that this level will also be linked to theory of mind abilities of children.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Preterm Birth and Social Cognition: of the Executive Functions and Parental Anxiety's Stakes
Actual Study Start Date : July 20, 2017
Estimated Primary Completion Date : February 20, 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: preterm children Behavioral: Evaluation of the children's social cognitive development
standardized neuropsychological tests

Active Comparator: term children Behavioral: Evaluation of the children's social cognitive development
standardized neuropsychological tests

Primary Outcome Measures :
  1. Social cognition / Theory of mind [ Time Frame: Day 0 ]
    small stories involving the thoughts and feelings of characters

  2. working memory [ Time Frame: Day 0 ]
    Executives functions

  3. shifting [ Time Frame: Day 0 ]
    Executives functions

  4. Trait Anxiety Inventory [ Time Frame: Day 0 ]
    Parent's psychological features

  5. Beck Depression Inventory [ Time Frame: Day 0 ]
    Parent's psychological features

  6. Social Support Questionnaire [ Time Frame: Day 0 ]
    Parent's psychological features

  7. Trauma [ Time Frame: Day 0 ]
    Parent's psychological features

  8. Parental Stress Index [ Time Frame: Day 0 ]
    Parent's psychological features

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

Preterm children:

  • Girls or boys born before 37 weeks of gestational age.
  • Aged between 7 to 10 years-old
  • At school

Term children:

  • Girls or boys born after 37 weeks of gestational age.
  • Aged between 6 and 10 years-old: 6 year-olds were included for the mental age matching with preterm children.
  • At school

Exclusion Criteria:

  • Children :

    • Child with a intrauterine growth failure
    • Child from multiple births
    • Child with organic malformation
    • Child with a genetic anomaly
    • Child with a neuromoteur pathology
    • Child with a global developmental delay (Intellectual quotient inferior to 80).
  • Parents :

    • Minor parent (less than 18 year old)
    • Parent with an intellectual disability
    • Parent with a psychotic syndrome
    • Parent who does not understand French

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 identifier (NCT number): NCT03007095

Contact: Rolland Anne-Catherine 3 26 78 85 58 ext 0033

Chu Reims Recruiting
Reims, France, 51092
Contact: Damien JOLLY    326788472 ext 33   
Sponsors and Collaborators
CHU de Reims

Responsible Party: CHU de Reims Identifier: NCT03007095     History of Changes
Other Study ID Numbers: PO16068
First Posted: January 2, 2017    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications